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U.S. Department of Health and Human Services

Current List of Accredited Persons for 510(k) Review under the FDA Modernization Act of 1997

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Database Updated 07/28/2014

This page provides information on persons accredited (as of the above date of revision) to review selected premarket notifications [510(k)s] and the devices they may review.  Information on this list will be updated within 10 working days after the date reflected on the third party's accreditation letter.  Each classified device type on the list of devices eligible for Third Party Review has one or more product codes associated with it.  Devices eligible for review by Third Parties are limited to the product codes shown on the list of eligible devices.  Please refer to the List of Devices for Third Party Review Under the FDA Modernization Act (FDAMA) of 1997 to assure your device is eligible for the Accredited Person Program. To-date, FDA has not withdrawn accreditation from any Accredited Person.
BSI HEALTHCARE
CENTER FOR MEASUREMENT STANDARDS OF INDUSTRIAL
DEKRA CERTIFICATION B.V.
NIOM - NORDIC INSTITUTE OF DENTAL MATERIALS
REGULATORY TECHNOLOGY SERVICES, LLC
THIRD PARTY REVIEW GROUP, LLC
TUV SUD AMERICA INC.
REGULATORY TECHNOLOGY SERVICES, LLC
1394 25TH STREET, NW
BUFFALO MN 55313
Contact:MR. MARK JOB,
Phone: 763 682 4139 ext
Fax: 763 682 4420
Email:
MARK@MARKJOB.COM
Internet:
www.markjob.com
PanelSection Number       Regulation Name / Device Name      Class
Anesthesiology
  868.1040 POWERED ALGESIMETER II
  868.1075 ARGON GAS ANALYZER II
  868.1150 INDWELLING BLOOD CARBON DIOXIDE PARTIAL PRESSURE (PCO2) ANALYZER II
  868.1170 INDWELLING BLOOD HYDROGEN ION CONCENTRATION (PH) ANALYZER II
  868.1200 INDWELLING BLOOD OXYGEN PARTIAL PRESSURE (P02) ANALYZER II
  868.1400 CARBON-DIOXIDE GAS ANALYZER II
  868.1430 CARBON-MONOXIDE GAS ANALYZER II
  868.1500 ENFLURANE GAS ANALYZER II
  868.1620 HALOTHANE GAS ANALYZER II
  868.1640 HELIUM GAS ANALYZER II
  868.1670 NEON GAS ANALYZER II
  868.1690 NITROGEN GAS ANALYZER II
  868.1700 NITROUS-OXIDE GAS ANALYZER II
  868.1720 OXYGEN GAS ANALYZER II
  868.1730 OXYGEN-UPTAKE COMPUTER II
  868.1750 PRESSURE PLETHYSMOGRAPH II
  868.1760 VOLUME PLETHYSMOGRAPH II
  868.1780 INSPIRATORY AIRWAY PRESSURE METER II
  868.1800 RHINOANEMOMETER II
  868.1840 DIAGNOSTIC SPIROMETER II
  868.1850 MONITORING SPIROMETER II
  868.1860 PEAK FLOW METER FOR SPIROMETRY II
  868.1880 PULMONARY FUNCTION DATA CALCULATOR II
  868.1890 PREDICTIVE PULMONARY FUNCTION VALUE CALCULATOR II
  868.1900 DIAGNOSTIC PULMONARY FUNCTION INTERPRETATION CALCULATOR II
  868.1920 ESOPYAGEAL STETHOSCOPE WITH ELECTRICAL CONDUCTORS II
  868.2025 ULTRASONIC AIR EMBOLISM MONITOR II
  868.2375 BREATHING FREQUENCY MONITOR II
  868.2385 NITROGEN DIOXIDE ANALYZER II
  868.2500 CUTANEOUS OXYGEN MONITOR II
  868.2600 AIRWAY PRESSURE MONITOR II
  868.2775 ELECTRICAL PERIPHERAL NERVE STIMULATOR II
  868.5090 EMERGENCY AIRWAY NEEDLE II
  868.5120 ANESTHESIA CONDUCTION CATHETER II
  868.5130 ANESTHESIA CONDUCTION FILTER II
  868.5140 ANESTHESIA CONDUCTION KIT II
  868.5150 ANESTHESIA CONDUCTION NEEDLE II
  868.5160 GAS MACHINE FOR ANESTHESIA II
  868.5170 LARYNGO-TRACHEAL TOPICAL ANESTHESIA APPLICATOR II
  868.5250 BREATHING CIRCUIT CIRCULATOR II
  868.5260 BREATHING CIRCUIT BACTERIAL FILTER II
  868.5270 BREATHING SYSTEM HEATER II
  868.5330 BREATHING GAS MIXER II
  868.5430 GAS-SCAVENGING APPARATUS II
  868.5440 PORTABLE OXYGEN GENERATOR II
  868.5470 HYPERBARIC CHAMBER II
  868.5630 NEBULIZER II
  868.5655 PORTABLE LIQUID OXYGEN UNIT II
  868.5665 POWERED PERCUSSOR II
  868.5690 INCENTIVE SPIROMETER II
  868.5710 ELECTRICALLY POWERED OXYGEN TENT II
  868.5730 TRACHEAL TUBE II
  868.5750 INFLATABLE TRACHEAL TUBE CUFF II
  868.5800 TRACHEOSTOMY TUBE AND TUBE CUFF II
  868.5870 NONREBREATHING VALVE II
  868.5880 ANESTHETIC VAPORIZER II
  868.5895 CONTINUOUS VENTILATOR II
  868.5905 NONCONTINUOUS VENTILATOR II
  868.5915 MANUAL EMERGENCY VENTILATOR II
  868.5925 POWERED EMERGENCY VENTILATOR II
  868.5935 EXTERNAL NEGATIVE PRESSURE VENTILATOR II
  868.5965 POSITIVE END EXPIRATORY PRESSURE ATTACHMENT II
  868.6250 PORTABLE AIR COMPRESSOR II
PanelSection Number       Regulation Name / Device Name      Class
Clinical Chemistry
  862.1020 ACID PHOSPHATASE (TOTAL OR PROSTATIC) TEST SYSTEM II
  862.1025 ADRENOCORTICOTROPIC HORMONE (ACTH) TEST SYSTEM II
  862.1035 ALBUMIN TEST SYSTEM II
  862.1045 ALDOSTERONE TEST SYSTEM II
  862.1050 ALKALINE PHOSPHATASE OR ISOENZYMES TEST SYSTEM II
  862.1065 AMMONIA TEST SYSTEM I
  862.1070 AMYLASE TEST SYSTEM II
  862.1085 ANGIOTENSIN I AND RENIN TEST SYSTEM II
  862.1090 ANGIOTENSIN CONVERTING ENZYME TEST SYSTEM II
  862.1100 ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM II
  862.1110 BILIRUBIN (TOTAL AND DIRECT) TEST SYSTEM II
  862.1113 BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM I
  862.1118 BIOTINIDASE TEST SYSTEM II
  862.1120 BLOOD GASES (PCO2, PO2) AND BLOOD PH TEST SYSTEM II
  862.1140 CALCITONIN TEST SYSTEM II
  862.1145 CALCIUM TEST SYSTEM II
  862.1150 CALIBRATOR II
  862.1155 HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM II
  862.1160 BICARBONATE/CARBON DIOXIDE TEST SYSTEM II
  862.1170 CHLORIDE TEST SYSTEM II
  862.1177 CHOLYLGLYCINE TEST SYSTEM II
  862.1187 CONJUGATED SULFOLITHOCHOLIC ACID (SLCG) TEST SYSTEM II
  862.1205 CORTISOL (HYDROCORTISONE AND HYDROXYCORTICOSTERONE) TEST SYSTEM II
  862.1215 CREATINE PHOSPHOKINASE/CREATINE KINASE OR ISOENZYMES TEST SYSTEM II
  862.1225 CREATININE TEST SYSTEM II
  862.1230 CYCLIC AMP TEST SYSTEM II
  862.1295 FOLIC ACID TEST SYSTEM II
  862.1310 GALACTOSE TEST SYSTEM I
  862.1315 GALACTOSE-1-PHOSPHATE URIDYLTRANSFERASE TEST SYSTEM II
  862.1340 URINARY GLUCOSE (NONQUANTITATIVE) TEST SYSTEM II
  862.1345 GLUCOSE TEST SYSTEM II
  862.1377 URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM II
  862.1410 IRON (NON-HEME) TEST SYSTEM I
  862.1415 IRON-BINDING CAPACITY TEST BINDING I
  862.1445 LACTATE DEHYDROGENASE ISOENZYMES TEST SYSTEM II
  862.1455 LECITHIN/SPHINGOMYELIN RATIO IN AMNIOTIC FLUD TEST SYSTEM II
  862.1495 MAGNESIUM TEST SYSTEM I
  862.1509 URINARY METHYLMALONIC ACID TEST SYSTEM II
  862.1545 PARATHYROID HORMONE TEST SYSTEM II
  862.1555 PHENYLALANINE TEST SYSTEM II
  862.1580 PHOSPHORUS (INORGANIC) TEST SYSTEM I
  862.1585 HUMAN PLACENTAL LACTOGEN TEST SYSTEM II
  862.1600 POTASSIUM TEST SYSTEM II
  862.1660 QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED) I
  862.1665 SODIUM TEST SYSTEM II
  862.1675 BLOOD SPECIMEN COLLECTION DEVICE II
  862.1680 TESTOSTERONE TEST SYSTEM I
  862.1685 THYROXINE-BINDING GLOBULIN TEST SYSTEM II
  862.1690 THYROID-STIMULATING HORMONE TEST SYSTEM II
  862.1695 FREE THYROXINE TEST SYSTEM II
  862.1700 TOTAL THYROXINE TEST SYSTEM II
  862.1730 FREE TYROSINE TEST SYSTEM I
  862.1770 UREA NITROGEN TEST SYSTEM II
  862.1775 URIC ACID TEST SYSTEM I
  862.1810 VITAMIN B12 TEST SYSTEMS II
  862.1825 VITAMIN D TEST SYTEM II
  862.2250 GAS LIQUID CHROMATOGRAPHY SYSTEM FOR CLINICAL USE I
PanelSection Number       Regulation Name / Device Name      Class
Cardiovascular
  870.1100 BLOOD PRESSURE ALARM II
  870.1110 BLOOD PRESSURE COMPUTER II
  870.1120 BLOOD PRESSURE CUFF II
  870.1130 NONINVASIVE BLOOD PRESSUE MEASUREMENT SYSTEM II
  870.1140 VENOUS BLOOD PRESSURE MANOMETER II
  870.1200 DIAGNOSTIC INTRAVASCULAR CATHETER II
  870.1210 CONTINOUS FLUSH CATHETER II
  870.1230 FIBEROPTIC OXIMETER CATHETER II
  870.1240 FLOW-DIRECTED CATHETER II
  870.1250 PERCUTANEOUS CATHETER II
  870.1270 INTRACAVITARY PHONOCATHETER SYSTEM II
  870.1280 STEERABLE CATHETER II
  870.1290 STEERABLE CATHETER CONTROL SYSTEM II
  870.1300 CATHETER CANNULA II
  870.1310 VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION II
  870.1330 CATHETER GUIDE WIRE II
  870.1340 CATHETER INTRODUCER II
  870.1370 CATHETER TIP OCCLUDER II
  870.1380 CATHETER STYLET II
  870.1390 TROCAR II
  870.1425 PROGRAMMABLE DIAGNOSTIC COMPUTER II
  870.1435 SINGLE-FUNCTION PREPROGRAMMED DIAGNOSTIC COMPUTER II
  870.1450 DENSITOMETER II
  870.1650 ANGIOGRAPHIC INJECTOR AND SYRINGE II
  870.1660 INDICATOR INJECTOR II
  870.1670 SYRINGE ACTUATOR FOR INJECTOR II
  870.1800 WITHDRAWAL-INFUSION PUMP II
  870.1875 STETHOSCOPE II
  870.1915 THERMODILUTION PROBE II
  870.2050 BIOPOTENTIAL AMPLIFIER AND SIGNAL CONDITIONER II
  870.2060 TRANSDUCER SIGNAL AMPLIFIER AND SIGNAL CONDITIONER II
  870.2100 CARDIOVASCULAR BLOOD FLOWMETER II
  870.2120 EXTRAVASCULAR BLOOD FLOW PROBE II
  870.2300 CARDIAC MONITOR (INCLUDING CARDIOTACHOMETER AND RATE ALARM) II
  870.2330 ECHOCARDIOGRAPH II
  870.2340 ELECTROCARDIOGRAPH II
  870.2350 ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR II
  870.2360 ELECTROCARDIOGRAPH ELECTRODE II
  870.2370 ELECTROCARDIOGRAPH SURFACE ELECTRODE TESTER II
  870.2400 VECTORCARDIOGRAPH II
  870.2450 MEDICAL CATHODE-RAY TUBE DISPLAY II
  870.2675 OSCILLOMETER II
  870.2750 IMPEDANCE PHLEBOGRAPH II
  870.2770 IMPEDANCE PLETHYSMOGRAPH II
  870.2780 HYDRAULIC, PNEUMATIC OR PHOTOELECTRIC PHETHYSMOGRAPH II
  870.2800 MEDICAL MAGNETIC TAPE RECORDER II
  870.2840 APEX CARDIOGRAPHIC TRANSDUCER II
  870.2850 EXTRAVASCULAR BLOOD PRESSURE TRANSDUCER II
  870.2860 HEART SOUND TRANSDUCER II
  870.2870 CATHETER TIP PRESSURE TRANSDUCER II
  870.2880 ULTRASONIC TRANSDUCER II
  870.2890 VESSEL OCCLUSION TRANSDUCER II
  870.2900 PATIENT TRANSDUCER AND ELECTRODE CABLE (INCLUDING CONNECTOR) II
  870.2910 RADIOFREQUENCY PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER II
  870.2920 TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER II
  870.3630 PACEMAKER GENERATOR FUNCTION ANALYZER II
  870.3640 INDIRECT PACEMAKER GENERATOR FUNCTION ANALYZER II
  870.3720 PACEMAKER ELECTRODE FUNCTION TESTER II
  870.4075 ENDOMYOCARDIAL BIOPSY DEVICE II
  870.4205 CARDIOPULMONARY BYPASS BUBBLE DETECTOR II
  870.4210 CARDIOPULMONARY BYPASS VASCULAR CATHETER, CANNULA, AND TUBING II
  870.4270 CARDIOPULMONARY BYPASS CARDIOTOMY SUCTION LINE BLOOD FILTER II
  870.4280 CARDIOPULMONARY PREBYPASS FILTER II
  870.4290 CARDIOPULMONARY BYPASS ADAPTOR, STOPCOCK, MANIFOLD, OR FITTING II
  870.4310 CARDIOPULMONARY BYPASS CORONARY PRESSURE GAUGE II
  870.4330 CARDIOPULMONARY BYPASS ON-LINE BLOOD GAS MONITOR II
  870.4340 CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR AND/OR CONTROL II
  870.4390 CARDIOPULMONARY BYPASS PUMP TUBING II
  870.4400 CARDIOPULMONARY BYPASS BLOOD RESERVOIR II
  870.4410 CARDIOPULMONARY BYPASS IN-LINE BLOOD GAS SENSOR II
  870.4420 CARDIOPULMONARY BYPASS CARDIOTOMY RETURN SUCKER II
  870.4430 CARDIOPULMONARY BYPASS INTRACARDIAC SUCTION CONTROL II
  870.4450 VASCULAR CLAMP II
  870.4475 SURGICAL VESSEL DILATOR II
  870.4875 INTRALUMINAL ARTERY STRIPPER II
  870.4885 EXTERNAL VEIN STRIPPER II
  870.5050 PATIENT CARE SUCTION APPARATUS II
  870.5150 EMBOLECTOMY CATHETER II
  870.5175 SEPTOSTOMY CATHETER II
  870.5325 DEFIBRILLATOR TESTER II
  870.5800 COMPRESSIBLE LIMB SLEEVE II
  870.5900 THERMAL REGULATION SYSTEM II
  870.5925 AUTOMATIC ROTATING TOURNIQUET II
PanelSection Number       Regulation Name / Device Name      Class
Dental
  872.1720 PULP TESTER II
  872.1740 CARIES DETECTION DEVICE II
  872.1800 EXTRAORAL SOURCE X-RAY SYSTEM II
  872.1810 INTRAORAL SOURCE X-RAY SYSTEM II
  872.1830 CEPHALOMETER II
  872.1870 IN VIVO SULFIDE DETECTION DEVICE II
  872.3060 GOLD BASED ALLOYS AND PRECIOUS METAL ALLOYS FOR CLINICAL USE II
  872.3200 RESIN TOOTH BONDING AGENT II
  872.3250 CALCIUM HYDROXIDE CAVITY LINER II
  872.3260 CAVITY VARNISH II
  872.3275 DENTAL CEMENT II
  872.3300 HYDROPHILIC RESIN COATING FOR DENTURES II
  872.3310 COATING MATERIAL FOR RESIN FILLINGS II
  872.3520 DENTURE CLEANSER I
  872.3540 OTC DENTURE PAD AND DENTURE CUSHION II
  872.3560 OTC DENTURE RELINER II
  872.3570 OTC DENTURE REPAIR KIT II
  872.3590 PREFORMED PLASTIC DENTURE TOOTH II
  872.3600 PARTIALLY FABRICATED DENTURE KIT II
  872.3660 IMPRESSION MATERIAL II
  872.3690 TOOTH SHADE RESIN MATERIAL II
  872.3710 BASE METAL ALLOY II
  872.3750 BRACKET ADHESIVE RESIN AND TOOTH CONDITIONER II
  872.3760 DENTURE RELINING REPAIRING OR REBASING RESIN II
  872.3765 PIT AND FISSURE SEALANT AND CONDITIONER II
  872.3770 TEMPORARY CROWN AND BRIDGE RESIN II
  872.3820 ROOT CANAL FILLING RESIN II
  872.3890 ENDODONTIC STABILIZER SPLINT II
  872.3920 PORCELAIN TOOTH II
  872.4120 BONE CUTTING INSTRUMENTS AND ACCESSORIES II
  872.4200 DENTAL HANDPIECES AND ACCESSORIES I
  872.4465 GAS POWERED JET INJECTOR II
  872.4475 SPRING-POWERED JET INJECTOR II
  872.4565 DENTAL HAND INSTRUMENT I
  872.4840 ROTARY SCALER II
  872.4850 ULTRASONIC SCALER II
  872.4920 ELECTROSURGICAL UNIT AND ACCESSORIES II
  872.5470 ORTHODONTIC PLASTIC BRACKET II
  872.5500 EXTRAORAL ORTHODONTIC HEADGEAR II
  872.5550 FLUID FILLED TEETHING RING II
  872.5570 INTRAORAL DEVICES FOR SNORING AND INTRAORAL DEVICES FOR SNORING AND OBSTRUCTIVE SLEEP APNEA II
  872.6070 ULTRAVIOLET ACTIVATOR FOR POLYMERIZATION II
  872.6080 AIRBRUSH II
  872.6250 CHAIR WITH A UNIT I
  872.6350 ULTRAVIOLET DETECTOR II
  872.6640 DENTAL OPERATIVE UNIT I
  872.6660 PORCELAIN POWDER FOR CLINICAL USE II
  872.6710 BOILING WATER STERILIZER I
  872.6770 CARTRIDGE SYRINGE II
PanelSection Number       Regulation Name / Device Name      Class
Ear Nose & Throat
  874.1090 AUDITORY IMPEDANCE TESTER II
  874.1120 ELECTRONIC NOISE GENERATOR FOR AUDIOMETRIC TESTING II
  874.1325 ELECTROGLOTTOGRAPH II
  874.1820 SURGICAL NERVE STIMULATOR/LOCATOR II
  874.3300 HEARING AID II
  874.3310 HEARING AID CALIBRATOR AND ANALYSIS SYSTEM II
  874.3320 GROUP HEARING AID OR GROUP AUDITORY TRAINER II
  874.3330 MASTER HEARING AID II
  874.3400 TINNITUS MASKER II
  874.3730 LARYNGEAL PROSTHESIS (TAUB DESIGN) II
  874.4250 EAR, NOSE, AND THROAT ELECTRIC OR PNEUMATIC SURGICAL DRILL II
  874.4500 ENT MICROSURGICAL CARBON DIOXIDE LASER PRODUCT II
  874.4680 BRONCHOSCOPE (FLEXIBLE OR RIGID) II
  874.4710 ESOPHAGOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES II
  874.4720 MEDIASTINOSCOPE AND ACCESSORIES II
  874.4760 NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES II
PanelSection Number       Regulation Name / Device Name      Class
Gastroenterology
  876.1075 GASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT II
  876.1500 ENDOSCOPE AND ACCESSORIES II
  876.1725 GASTROINTESTINAL MOTILITY MONITORING SYSTEM II
  876.4020 FIBEROPTIC LIGHT URETERAL CATHETER II
  876.4270 COLOSTOMY ROD II
  876.4300 ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES II
  876.4400 HEMORRHOIDAL LIGATOR II
  876.4480 ELECTROHYDRAULIC LITHOTRIPTOR II
  876.4500 MECHANICAL LITHOTRIPTOR II
  876.4620 URETERAL STENT II
  876.4770 URETHROTOME II
  876.5010 BILIARY CATHETER AND ACCESSORIES II
  876.5090 SUPRAPUBIC UROLOGICAL CATHETER AND ACCESSORIES II
  876.5130 UROLOGICAL CATHETER AND ACCESSORIES II
  876.5160 UROLOGICAL CLAMPS FOR MALES I
  876.5320 NONIMPLANTED ELECTRICAL CONTINENCE DEVICE II
  876.5365 ESOPHAGEAL DILATOR II
  876.5470 URETERAL DILATOR II
  876.5520 URETHRAL DILATOR II
  876.5540 BLOOD ACCESS DEVICE AND ACCESSORIES II
  876.5665 WATER PURIFICATION SYSTEM FOR DIALYSIS II
  876.5880 ISOLATED KIDNEY PERFUSION AND TRANSPORT SYSTEM AND ACCESSORIES II
  876.5895 OSTOMY IRRIGATOR II
  876.5980 GASTROINTESTINAL TUBE AND ACCESSORIES II
PanelSection Number       Regulation Name / Device Name      Class
Hematology
  864.1860 IMMUNOHISTOCHEMISTRY REAGENTS AND KITS II
  864.5260 AUTOMATED CELL-LOCATING DEVICE II
  864.5300 RED CELL INDICES DEVICE II
  864.5425 MULTIPURPOSE SYSTEM FOR IN VITRO COAGULATION STUDIES II
  864.5600 AUTOMATED HEMATOCRIT INSTRUMENT II
  864.5620 AUTOMATED HEMOGLOBIN SYSTEM II
  864.5950 BLOOD VOLUME MEASURING DEVICE II
  864.6550 OCCULT BLOOD TEST II
  864.7040 ADENOSINE TRIPHOSPHATE RELEASE ASSAY I
  864.7100 RED BLOOD CELL ENZYME ASSAY II
  864.7250 ERYTHROPOIETIN ASSAY II
  864.7275 EUGLOBULIN LYSIS TIME TESTS II
  864.7300 FIBRIN MONOMER PARACOAGULATION TEST II
  864.7320 FIBRINOGEN/FIBRIN DEGRADATION PRODUCTS ASSAY II
  864.7340 FIBRINOGEN DETERMINATION SYSTEM II
  864.7360 ERYTHROCYTIC GLUCOSE-6-PHOSPHATE DEHYDROGENASE ASSAY II
  864.7375 GLUTATHIONE REDUCTASE ASSAY II
  864.7400 HEMOGLOBIN A2 ASSAY II
  864.7415 ABNORMAL HEMOBLOBIN ASSAY II
  864.7425 CARBOXYHEMOGLOBIN ASSAY II
  864.7440 ELECTROPHORETIC HEMOGLOBIN ANALYSIS SYSTEM II
  864.7455 FETAL HEMOGLOBIN ASSAY II
  864.7470 GLYCOSYLATED HEMOGLOBIN ASSAY II
  864.7490 SULFHEMOGLOBIN ASSAY II
  864.7500 WHOLE BLOOD HEMOBLOBIN ASSAYS II
  864.7825 SICKLE CELL TEST II
  864.8100 BOTHROPS ATROX REAGENT II
  864.8150 CALIBRATOR FOR CELL INDICES II
  864.8165 CALBRATOR FOR HEMOGLOBIN OR HEMATOCRIT MEASUREMENT II
  864.8175 CALIBRATOR FOR PLATELET COUNTING II
  864.8185 CALIBRATOR FOR RED CELL AND WHITE CELL COUNTING II
  864.8625 HEMATOLOGY QUALITY CONTROL MIXTURE II
  864.8950 RUSSEL VIPER VENOM REAGENT I
PanelSection Number       Regulation Name / Device Name      Class
General Hospital
  880.2420 ELECTRONIC MONITOR FOR GRAVITY FLOW INFUSION SYSTEMS II
  880.2460 ELECTRICALLY POWERED SPINAL FLUID PRESSURE MONITOR II
  880.2500 SPINAL FLUID MANOMETER II
  880.2800 STERILIZATION PROCESS INDICATOR II
  880.2910 CLINICAL ELECTRONIC THERMOMETER II
  880.5025 I.V. CONTAINER II
  880.5045 MEDICAL RECIRCULATING AIR CLEANER II
  880.5090 LIQUID BANDAGE I
  880.5130 INFANT RADIANT WARMER II
  880.5200 INTRAVASCULAR CATHETER II
  880.5400 NEONATAL INCUBATOR II
  880.5410 NEONATAL TRANSPORT INCUBATOR II
  880.5430 NONELECTRICALLY POWERED FLUID INJECTOR II
  880.5440 INTRAVASCULAR ADMINISTRATION SET II
  880.5450 PATIENT CARE REVERSE ISOLATION CHAMBER II
  880.5570 HYPODERMIC SINGLE LUMEN NEEDLE II
  880.5580 NEEDLE, ACUPUNCTURE, SINGLE USE II
  880.5680 PEDIATRIC POSITION HOLDER I
  880.5700 NEONATAL PHOTOTHERAPY UNIT II
  880.5725 INFUSION PUMP II
  880.5780 MEDICAL SUPPORT STOCKING II
  880.5860 PISTON SYRINGE II
  880.6100 ETHYLENE OXIDE GAS AERATOR CABINET II
  880.6250 PATIENT EXAMINATION GLOVE I
  880.6375 PATIENT LUBRICANT I
  880.6500 MEDICAL ULTRAVIOLET AIR PURIFIER II
  880.6710 MEDICAL ULTRAVIOLET WATER PURIFIER II
  880.6760 PROTECTIVE RESTRAINT I
  880.6850 STERILIZATION WRAP II
  880.6860 ETHYLENE OXIDE GAS STERILIZER II
  880.6870 DRY-HEAT STERILIZER II
  880.6880 STEAM STERILIZER II
  880.6885 LIQUID CHEMICAL STERILANTS/HIGH LEVEL DISINFECTANTS II
  880.6920 SYRINGE NEEDLE INTRODUCER II
PanelSection Number       Regulation Name / Device Name      Class
Immunology
  866.5080 ALPHA-1-ANTICHYMOTRYPSIN IMMUNOLOGICAL TEST SYSTEM II
  866.5090 ANTIMITOCHONDRIAL ANTIBODY IMMUNOLOGICAL TEST SYSTEM II
  866.5100 ANTINUCLEAR ANTIBODY IMMUNOLOGICAL TEST SYSTEM II
  866.5120 ANTISMOOTH MUSCLE ANTIBODY IMMUNOLOGICAL TEST SYSTEM II
  866.5130 ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL TEST SYSTEM II
  866.5150 BENCE-JONES PROTEINS IMMUNOLOGICAL TEST SYSTEM II
  866.5240 COMPLEMENT COMPONENTS IMMUNOLOGICAL TEST SYSTEM II
  866.5250 COMPLEMENT C1 INHIBITOR (INACTIVATOR) IMMUNOLOGICAL TEST SYSTEM II
  866.5260 COMPLEMENT C3B INACTIVATOR IMMUNOLOGICAL TEST SYSTEM II
  866.5270 C-REACTIVE PROTEIN IMMUNOLOGICAL TEST SYSTEM II
  866.5340 FERRITIN IMMUNOLOGICAL TEST SYSTEM II
  866.5350 FIBRINOPEPTIDE A IMMUNOLOGICAL TEST SYSTEM II
  866.5510 IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST SYSTEM II
  866.5550 IMMUNOGLOBULIN (LIGHT CHAIN SPECIFIC) IMMUNOLOGICAL TEST SYSTEM II
  866.5580 ALPHA-1-LIPOPROTEIN IMMUNOLOGICAL TEST SYSTEM II
  866.5600 LOW-DENSITY LIPOPROTEIN IMMUNOLOGICAL TEST SYSTEM II
  866.5620 ALPHA-2-MACROGLOBULIN IMMUNOLOGICAL TEST SYSTEM II
  866.5630 BETA-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM II
  866.5640 INFECTIOUS MONONUCLEOSIS IMMUNOLOGICAL TEST SYSTEM II
  866.5680 MYOGLOBIN IMMUNOLOGICAL TEST SYSTEM II
  866.5775 RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM II
  866.5820 SYSTEMIC LUPUS ERYTHEMATOSUS IMMUNOLOGICAL TEST SYSTEM II
  866.5870 THYROID AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM II
  866.5880 TRANSFERRIN IMMUNOLOGICAL TEST SYSTEM II
PanelSection Number       Regulation Name / Device Name      Class
Microbiology
  866.1620 ANTIMICROBIAL SUSCEPTIBILITY TEST DISC II
  866.1640 ANTIMICROBIAL SUSCEPTIBILITY TEST POWDER II
  866.1700 CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEPTIBILITY TESTS II
  866.2390 TRANSPORT CULTURE MEDIUM I
  866.2560 MICROBIAL GROWTH MONITOR I
  866.2850 AUTOMATED ZONE READER I
  866.2900 MICROBIOLOGICAL SPECIMEN COLLECTION AND TRANSPORT DEVICE I
  866.3110 CAMPYLOBACTER FETUS SEROLOGICAL REAGENTS I
  866.3120 CHLAMYDIA SEROLOGICAL REAGENTS I
  866.3175 CYTOMEGALOVIRUS SEROLOGICAL REAGENTS II
  866.3235 EPSTEIN-BARR VIRUS SEROLOGICAL REAGENTS I
  866.3370 MYCOBACTERIUM TUBERCULOSIS IMMUNOFLUORESCENT REAGENTS I
  866.3390 NEISSERA SPP. DIRECT SEROLOGICAL TEST REAGENTS II
  866.3510 RUBELLA VIRUS SEROLOGICAL REAGENTS II
  866.3780 TOXOPLASMA GONDII SEROLOGICAL REAGENTS II
  866.3820 TREPONEMA PALLIDUM NONTREPONEMAL TEST REAGENTS II
  866.3830 TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS II
  866.3870 TRYPANOSOMA SPP. SEROLOGICAL REAGENTS I
  866.3900 VARICELLA-ZOSTER VIRUS SEROLOGICAL REAGENTS II
PanelSection Number       Regulation Name / Device Name      Class
Neurology
  882.1020 RIGIDITY ANALYZER II
  882.1030 ATAXIAGRAPH I
  882.1240 ECHOENCEPHALOGRAPH II
  882.1275 ELECTROCONDUCTIVE MEDIA II
  882.1310 CORTICAL ELECTRODE II
  882.1320 CUTANEOUS ELECTRODE II
  882.1330 DEPTH ELECTRODES II
  882.1340 NASOPHARYNGEAL ELECTRODE II
  882.1350 NEEDLE ELECTRODE II
  882.1400 ELECTROENCEPHALOGRAPH II
  882.1420 ELECTROENCEPHALOGRAM (EEG) SIGNAL SPECTRUM ANALYZER I
  882.1460 NYSTAGMOGRAPH II
  882.1480 NEUROLOGICAL ENDOSCOPE II
  882.1540 GALVANIC SKIN RESPONSE MEASUREMENT DEVICE II
  882.1550 NERVE CONDUCTION VELOCITY MEASUREMENT DEVICE II
  882.1560 SKIN POTENTIAL MEASUREMENT DEVICE II
  882.1570 POWERED DIRECT CONTACT TEMPERATURE MEASUREMENT DEVICE II
  882.1610 ALPHA MONITOR II
  882.1620 INTRACRANIAL PRESSURE MONITORING DEVICE II
  882.1835 PHYSIOLOGICAL SIGNAL AMPLIFIER II
  882.1845 PHYSIOLOGICAL SIGNAL CONDITIONER II
  882.1855 ELECTROENCEPLELOGRAM (EEG) TELEMETRY SYSTEM II
  882.1870 EVOKED RESPONSE ELECTRICAL STIMULATOR II
  882.1880 EVOKED RESPONSE MECHANICAL STIMULATOR II
  882.1890 EVOKED RESPONSE PHOTIC STIMULATOR II
  882.1900 EVOKED RESPONSE AUDITORY STIMULATOR II
  882.1950 TREMOR TRANSDUCER II
  882.4060 VENTRICULAR CANNULA I
  882.4100 VENTRICULAR CATHETER II
  882.4150 SCALP CLIP II
  882.4175 ANEURYSM CLIP APPLIER II
  882.4250 CRYOGENIC SURGICAL DEVICE II
  882.4275 DOWEL CUTTING INSTRUMENT II
  882.4300 MANUAL CRANIAL DRILLS, BURRS, TREPHINES & ACCESSORIES II
  882.4305 POWERED COMPOUND CRANIAL DRILLS, BURRS, TREPHINES & ACCESSORIES II
  882.4310 POWERED SIMPLE CRANIAL DRILLS, BURRS, TREPHINES & ACCESSORIES II
  882.4360 ELECTRIC CRANIAL DRILL MOTOR II
  882.4370 PNEUMATIC CRANIAL DRILL MOTOR II
  882.4400 RADIOFREQUENCY LESION GENERATOR II
  882.4460 NEUROSURGICAL HEAD HOLDER (SKULL CLAMP) II
  882.4545 SHUNT SYSTEM IMPLANTATION INSTRUMENT I
  882.4560 STEREOTAXIC INSTRUMENT II
  882.4700 COTTONOID PADDIE II
  882.4725 RADIOFREQUENCY LESION PROBE II
  882.4800 SELF-RETAINING RETRACTOR FOR NEUROSURGERY II
  882.4840 MANUAL RONGEUR II
  882.4845 POWERED RONGEUR II
  882.5070 BITE BLOCK II
  882.5235 AVERSIVE CONDITIONING DEVICE II
  882.5500 LESION TEMPERATURE MONITOR II
  882.5550 CENTRAL NERVOUS SYSTEM FLUID SHUNTS AND COMPONENTS II
  882.5810 EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR II
  882.5890 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR FOR PAIN RELIEF II
  882.5960 SKULL TONG FOR TRACTION II
PanelSection Number       Regulation Name / Device Name      Class
Obstetrics/Gynecology
  884.1050 ENDOCERVICAL ASPIRATOR II
  884.1060 ENDOMETRIAL ASPIRATOR II
  884.1100 ENDOMETRIAL BRUSH II
  884.1175 ENDOMETRIAL SUCTION CURETTE AND ACCESSORIES II
  884.1185 ENDOMETRIAL WASHER II
  884.1300 UTEROTUBAL CARBON DIOXIDE INSUFFLATOR AND ACCESSORIES II
  884.1560 FETAL BLOOD SAMPLER II
  884.1630 COLPOSCOPE (AND COLPOMICROSCOPE) II
  884.1660 TRANSCERVICAL ENDOSCOPE (AMNIOSCOPE) AND ACCESSORIES II
  884.1690 HYSTEROSCOPE AND ACCESSORIES II
  884.1700 HYSTEROSCOPIC INSUFFLATOR II
  884.1720 GYNECOLOGIC LAPAROSCOPE AND ACCESSORIES II
  884.1730 LAPAROSCOPIC INSUFFLATOR II
  884.2225 OBSTETRIC-GYNECOLOGIC ULTRASONIC IMAGER II
  884.2600 FETAL CARDIAC MONITOR II
  884.2640 FETAL PHONOCARDIOGRAPHIC MONITOR AND ACCESSORIES II
  884.2660 FETAL ULTRASONIC MONITOR AND ACCESSORIES II
  884.2675 FETAL SCALP CIRCULAR (SPIRAL) ELECTRODE AND APPLICATOR II
  884.2700 INTRAUTERINE PRESSURE MONITOR AND ACCESSORIES II
  884.2720 EXTERNAL UTERINE CONTRACTION MONITOR AND ACCESSORIES II
  884.2740 PERINATAL MONITORING SYSTEM AND ACCESSORIES II
  884.2960 OBSTETRIC ULTRASONIC TRANSDUCER AND ACCESSORIES II
  884.2980 TELETHERMOGRAPHIC SYSTEM I
  884.2982 LIQUID CRYSTAL THERMOGRAPHIC SYSTEM I
  884.3200 CERVICAL DRAIN II
  884.3575 VAGINAL PESSARY II
  884.3900 VAGINAL STENT II
  884.4120 GYNECOLOGIC ELECTROCAUTERY AND ACCESSORIES II
  884.4160 UNIPOLAR ENDOSCOPIC COAGULATOR-CUTTER AND ACCESSORIES II
  884.4260 HYGROSCOPIC-LAMINARIA CERVICAL DILATOR II
  884.4340 FETAL VACUUM EXTRACTOR II
  884.4400 OBSTETRIC FORCEPS II
  884.4500 OBSTETRIC FETAL DESTRUCTIVE INSTRUMENT II
  884.4530 OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT II
  884.4550 GYNECOLOGIC SURGICAL LASER II
  884.4900 OBSTETRIC TABLE AND ACCESSORIES II
  884.5070 VACUUM ABORTION SYSTEM II
  884.5100 OBSTETRIC ANESTHESIA SET II
  884.5160 POWERED BREAST PUMP II
  884.5250 CERVICAL CAP II
  884.5300 CONDOM II
  884.5310 CONDOM WITH SPERMICIDAL LUBRICANT II
  884.5350 CONTRACEPTIVE DIAPHRAGM (AND ACCESSORIES) II
  884.5390 PERINEAL HEATER II
  884.5400 MENSTRUAL CUP II
  884.5425 SCENTED OR SCENTED DEODORIZED MENSTRUAL PAD II
  884.5460 SCENTED OR SCENTED DEODORIZED MENSTRUAL TAMPON II
  884.5470 UNSCENTED MENSTRUAL TAMPON II
  884.5960 GENITAL VIBRATOR FOR THERAPEUTIC USE II
  884.6100 ASSISTED REPRODUCTION NEEDLE II
  884.6110 ASSISTED REPRODUCTION CATHETER II
  884.6120 ASSISTED REPRODUCTION ACCESSORY II
  884.6130 ASSISTED REPRODUCTION MICROTOOLS II
  884.6140 ASSISTED REPRODUCTION MICROTOOL FABRICATION INSTRUMENTATION II
  884.6150 ASSISTED REPRODUCTION MICROMANIPULATORS AND MICROINJECTORS II
  884.6160 ASSISTED REPRODUCTION LABWARE II
  884.6180 REPRODUCTIVE MEDIA AND SUPPLEMENTS II
  884.6190 ASSISTED REPRODUCTION MICROSCOPE AND MICROSCOPE ACCESSORIES I
PanelSection Number       Regulation Name / Device Name      Class
Physical Medicine
  890.1225 CHRONAXIMETER II
  890.1375 DIAGNOSTIC ELECTROMYOGRAPH II
  890.1385 DIAGNOSTIC ELECTROMYOGRAPH NEEDLE ELECTRODE II
  890.1450 POWERED REFLEX HAMMER II
  890.1850 DIAGNOSTIC MUSCLE STIMULATOR II
  890.3110 ELECTRIC POSITIONING CHAIR II
  890.3690 POWERED WHEELED STRETCHER II
  890.3800 MOTORIZED THREE-WHEELED VEHICLE II
  890.3850 MECHANICAL WHEELCHAIR I
  890.3860 POWERED WHEELCHAIR II
  890.3880 SPECIAL GRADE WHEELCHAIR II
  890.3900 STANDUP WHEELCHAIR II
  890.3930 WHEELCHAIR ELEVATOR II
  890.5100 IMMERSION HYDROBATH II
  890.5110 PARAFFIN BATH II
  890.5150 POWERED PATIENT TRANSPORT II
  890.5250 MOIST STEAM CABINET II
  890.5275 MICROWAVE DIATHERMY II
  890.5290 SHORTWAVE DIATHERMY II
  890.5300 ULTRASONIC DIATHERMY II
  890.5360 MEASURING EXERCISE EQUIPMENT II
  890.5500 INFRARED LAMP II
  890.5525 IONTOPHORESIS DEVICE II
  890.5575 POWERED EXTERNAL LIMB OVERLOAD WARNING DEVICE II
  890.5650 POWERED INFLATABLE TUBE MASSAGER II
  890.5710 HOT OR COLD DISPOSABLE PACK I
  890.5850 POWERED MUSCLE STIMULATOR II
  890.5860 ULTRASOUND AND MUSCLE STIMULATOR II
  890.5880 MULTI-FUNCTION PHYSICAL THERAPY TABLE II
  890.5900 POWERED TRACTION EQUIPMENT II
PanelSection Number       Regulation Name / Device Name      Class
Radiology
  892.1000 MAGNETIC RESONANCE DIAGNOSTIC DEVICE II
  892.1100 SCINTILLATION GAMMA CAMERA I
  892.1110 POSITRON CAMERA I
  892.1170 BONE DENSITOMETER II
  892.1200 EMISSION COMPUTED TOMOGRAPHY SYSTEM II
  892.1220 FLUORESCENT SCANNER II
  892.1310 NUCLEAR TOMOGRAPHIC SYSTEM II
  892.1360 RADIONUCLIDE DOSE CALIBRATOR II
  892.1390 RADIONUCLIDE REBREATHING SYSTEM II
  892.1540 NONFETAL ULTRASONIC MONITOR II
  892.1550 ULTRASONIC PULSED DOPPLER IMAGING SYSTEM II
  892.1560 ULTRASONIC PULSED ECHO IMAGING SYSTEM II
  892.1570 DIAGNOSTIC ULTRASONIC TRANSDUCER II
  892.1600 ANGIOGRAPHIC X-RAY SYSTEM II
  892.1610 DIAGNOSTIC X-RAY BEAM LIMITING DEVICE II
  892.1620 CINE OR SPOT FLUOROGRAPHIC X-RAY CAMERA II
  892.1630 ELECTROSTATIC X-RAY IMAGING SYSTEM II
  892.1650 IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM II
  892.1660 NON-IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM II
  892.1670 SPOT FILM DEVICE II
  892.1680 STATIONARY X-RAY SYSTEM II
  892.1710 MAMMOGRAPHIC X-RAY SYSTEM II
  892.1720 MOBILE X-RAY SYSTEM II
  892.1730 PHOTOFLUOROGRAPHIC X-RAY SYSTEM II
  892.1740 TOMOGRAPHIC X-RAY SYSTEM II
  892.1750 COMPUTED TOMOGRAPHY X-RAY SYSTEM II
  892.1820 PNEUMOENCEPHALOGRAPHIC CHAIR II
  892.1850 RADIOGRAPHIC FILM CASSETTE II
  892.1860 RADIOGRAPHIC FILM/CASSETTE CHANGER II
  892.1870 RADIOGRAPHIC FILM/CASSETTE CHANGER PROGRAMMER II
  892.1900 AUTOMATIC RADIOGRAPHIC-FILM PROCESSOR II
  892.2030 MEDICAL IMAGE DIGITIZER II
  892.2040 MEDICAL IMAGE HARDCOPY DEVICE II
  892.2050 PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS II
  892.5050 MEDICAL CHARGED-PARTICLE RADIATION THERAPY SYSTEM II
  892.5300 MEDICAL NEUTRON RADIATION THERAPY SYSTEM II
  892.5700 REMOTE CONTROLLED RADIONUCLIDE-APPLICATOR SYSTEM II
  892.5710 RADIATION THERAPY BEAM-SHAPING BLOCK II
  892.5730 RADIONUCLIDE BRACHYTHERAPY SOURCE II
  892.5750 RADIONUCLIDE RADIATION THERAPY SYSTEM II
  892.5770 POWERED RADIATION THERAPY PATIENT SUPPORT ASSEMBLY II
  892.5840 RADIATION THERAPY SIMULATION SYSTEM II
  892.5900 X-RAY RADIATION THERAPY SYSTEM II
  892.5930 THERAPEUTIC X-RAY TUBE HOUSING ASSEMBLY II
PanelSection Number       Regulation Name / Device Name      Class
General & Plastic Surgery
  878.4040 SURGICAL APPAREL II
  878.4350 CRYOSURGICAL UNIT AND ACCESSORIES II
  878.4370 SURGICAL DRAPE AND DRAPE ACCESSORIES II
  878.4400 ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES II
  878.4460 SURGEON'S GLOVES I
  878.4580 SURGICAL LAMP II
  878.4630 DERMATOLOGIC ULTRAVIOLET LAMP II
  878.4780 POWERED SUCTION PUMP II
  878.4810 LASER SURGICAL INSTRUMENT FOR USE IN GENERAL & PLASTIC SURGERY & IN DERMATOLOGY II
  878.5040 SUCTION LIPOPLASTY SYSTEM II
  878.5070 AIR-HANDLING APPARATUS FOR A SURGICAL OPERATING ROOM II
PanelSection Number       Regulation Name / Device Name      Class
Toxicology
  862.3030 ACETAMINOPHEN TEST SYSTEM II
  862.3035 AMIKACIN TEST SYSTEM II
  862.3040 ALCOHOL TEST SYSTEM II
  862.3050 BREATH-ALCOHOL TEST SYSTEM I
  862.3100 AMPHETAMINE TEST SYSTEM II
  862.3110 ANTIMONY TEST SYSTEM I
  862.3120 ARSENIC TEST SYSTEM I
  862.3150 BARBITURATE TEST SYSTEM II
  862.3170 BENZODIAZEPINE TEST SYSTEM II
  862.3200 CLINICAL TOXICOLOGY CALIBRATOR II
  862.3220 CARBON MONOXIDE TEST SYSTEM I
  862.3240 CHOLINESTERASE TEST SYSTEM I
  862.3250 COCAINE AND COCAINE METABOLITE TEST SYSTEM II
  862.3270 CODEINE TEST SYSTEM II
  862.3280 CLINICAL TOXICOLOGY CONTROL MATERIAL I
  862.3300 DIGITOXIN TEST SYSTEM II
  862.3320 DIGOXIN TEST SYSTEM II
  862.3350 DIPHENYLHYDANTOIN TEST SYSTEM II
  862.3380 ETHOSUXIMIDE TEST SYSTEM II
  862.3450 GENTAMICIN TEST SYSTEM II
  862.3520 KANAMYCIN TEST SYSTEM II
  862.3550 LEAD TEST SYSTEM II
  862.3555 LIDOCAINE TEST SYSTEM II
  862.3560 LITHIUM TEST SYSTEM II
  862.3580 LYSERGIC ACID DIETHYLAMIDE (LSD) TEST SYSTEM II
  862.3600 MERCURY TEST SYSTEM I
  862.3610 METHAMPHETAMINE TEST SYSTEM II
  862.3620 METHADONE TEST SYSTEM II
  862.3630 METHAQUALONE TEST SYSTEM II
  862.3640 MORPHINE TEST SYSTEM II
  862.3645 NEUROLEPTIC DRUGS RADIORECEPTOR ASSAY TEST SYSTEM II
  862.3650 OPIATE TEST SYSTEM II
  862.3660 PHENOBARBITAL TEST SYSTEM II
  862.3670 PHENOTHIAZINE TEST SYSTEM II
  862.3680 PRIMIDONE TEST SYSTEM II
  862.3700 PROPOXYHPENE TEST SYSTEM II
  862.3750 QUININE TEST SYSTEM I
  862.3830 SALICYLATE TEST SYSTEM II
  862.3850 SULPHANIMIDE TEST SYSTEM I
  862.3880 THEOPHYLLINE TEST SYSTEM II
  862.3900 TOBRAMYCIN TEST SYSTEM II
  862.3910 TRICYCLIC ANTIDEPRESSANT DRUGS TEST SYSTEM II
  862.3950 VANCOMYCIN TEST SYSTEM II
 unclassified PHENCYCLIDINE (PCP) TEST SYSTEM: THIN LAYER CHROMATOGRAPHY  
 unclassified PHENCYCLIDINE (PCP) TEST SYSTEM: RADIOIMMUNOASSAY  
 unclassified PHENCYCLIDINE (PCP) TEST SYSTEM: ENZYME IMMUNOASSAY  
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