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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 To-date, FDA has not withdrawn accreditation from any Accredited Person.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.
CENTER FOR MEASUREMENT STANDARDS OF INDUSTRIAL
BLDG. 16, 321 KUANG FU RD,SEC2
HSINCHU,
CHINA (TAIWAN)
Contact: ALBERT T.W. LI, MANAGER, OFFICE OF MEDICAL DEVICE EVALUATION
Phone:886 357 32227 ext
Fax:886 357 32299
Email:
ALBERTTWLI@ITRI.ORG.TW
Internet:
PanelSection Number       Regulation Name / Device Name      Class
Anesthesiology
  868.5630 NEBULIZER II
PanelSection Number       Regulation Name / Device Name      Class
Clinical Chemistry
  862.1065 AMMONIA TEST SYSTEM I
  862.1113 BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM I
  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
  862.1225 CREATININE TEST SYSTEM II
  862.1310 GALACTOSE TEST SYSTEM I
  862.1340 URINARY GLUCOSE (NONQUANTITATIVE) TEST SYSTEM II
  862.1345 GLUCOSE TEST SYSTEM II
  862.1410 IRON (NON-HEME) TEST SYSTEM I
  862.1415 IRON-BINDING CAPACITY TEST BINDING I
  862.1495 MAGNESIUM TEST SYSTEM I
  862.1580 PHOSPHORUS (INORGANIC) TEST SYSTEM I
  862.1600 POTASSIUM TEST SYSTEM II
  862.1660 QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED) I
  862.1665 SODIUM TEST SYSTEM II
  862.1680 TESTOSTERONE TEST SYSTEM I
  862.1730 FREE TYROSINE TEST SYSTEM I
  862.1770 UREA NITROGEN TEST SYSTEM II
  862.1775 URIC ACID TEST SYSTEM I
PanelSection Number       Regulation Name / Device Name      Class
Cardiovascular
  870.1120 BLOOD PRESSURE CUFF II
  870.1130 NONINVASIVE BLOOD PRESSUE MEASUREMENT SYSTEM 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
  870.2880 ULTRASONIC TRANSDUCER II
PanelSection Number       Regulation Name / Device Name      Class
Dental
  872.1800 EXTRAORAL SOURCE X-RAY SYSTEM II
  872.1810 INTRAORAL SOURCE X-RAY SYSTEM II
  872.3060 GOLD BASED ALLOYS AND PRECIOUS METAL ALLOYS FOR CLINICAL USE II
  872.3200 RESIN TOOTH BONDING AGENT II
  872.3275 DENTAL CEMENT II
  872.3660 IMPRESSION MATERIAL II
  872.3690 TOOTH SHADE RESIN MATERIAL II
  872.3710 BASE METAL ALLOY II
  872.4200 DENTAL HANDPIECES AND ACCESSORIES I
  872.6250 CHAIR WITH A UNIT I
  872.6640 DENTAL OPERATIVE UNIT I
  872.6710 BOILING WATER STERILIZER I
PanelSection Number       Regulation Name / Device Name      Class
Gastroenterology
  876.1075 GASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT II
  876.1500 ENDOSCOPE AND ACCESSORIES II
  876.4300 ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES II
  876.4480 ELECTROHYDRAULIC LITHOTRIPTOR II
  876.4500 MECHANICAL LITHOTRIPTOR II
  876.4620 URETERAL STENT II
  876.5010 BILIARY 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
  876.5665 WATER PURIFICATION SYSTEM FOR DIALYSIS II
PanelSection Number       Regulation Name / Device Name      Class
General Hospital
  880.2910 CLINICAL ELECTRONIC THERMOMETER II
  880.5090 LIQUID BANDAGE I
  880.5200 INTRAVASCULAR CATHETER II
  880.5400 NEONATAL INCUBATOR II
  880.5410 NEONATAL TRANSPORT INCUBATOR II
  880.5440 INTRAVASCULAR ADMINISTRATION SET II
  880.5570 HYPODERMIC SINGLE LUMEN NEEDLE II
  880.5680 PEDIATRIC POSITION HOLDER I
  880.5725 INFUSION PUMP II
  880.5860 PISTON SYRINGE II
  880.6250 PATIENT EXAMINATION GLOVE I
  880.6375 PATIENT LUBRICANT I
  880.6760 PROTECTIVE RESTRAINT I
  880.6880 STEAM STERILIZER II
  880.6885 LIQUID CHEMICAL STERILANTS/HIGH LEVEL DISINFECTANTS II
PanelSection Number       Regulation Name / Device Name      Class
Microbiology
  866.1620 ANTIMICROBIAL SUSCEPTIBILITY TEST DISC II
  866.1640 ANTIMICROBIAL SUSCEPTIBILITY TEST POWDER 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
  866.3235 EPSTEIN-BARR VIRUS SEROLOGICAL REAGENTS I
  866.3370 MYCOBACTERIUM TUBERCULOSIS IMMUNOFLUORESCENT REAGENTS I
  866.3870 TRYPANOSOMA SPP. SEROLOGICAL REAGENTS I
PanelSection Number       Regulation Name / Device Name      Class
Neurology
  882.1030 ATAXIAGRAPH I
  882.1240 ECHOENCEPHALOGRAPH II
  882.1310 CORTICAL ELECTRODE II
  882.1400 ELECTROENCEPHALOGRAPH II
  882.1420 ELECTROENCEPHALOGRAM (EEG) SIGNAL SPECTRUM ANALYZER I
  882.1480 NEUROLOGICAL ENDOSCOPE II
  882.4060 VENTRICULAR CANNULA I
  882.4545 SHUNT SYSTEM IMPLANTATION INSTRUMENT I
  882.5890 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR FOR PAIN RELIEF II
PanelSection Number       Regulation Name / Device Name      Class
Obstetrics/Gynecology
  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
  884.2660 FETAL ULTRASONIC MONITOR AND ACCESSORIES II
  884.2960 OBSTETRIC ULTRASONIC TRANSDUCER AND ACCESSORIES II
  884.2980 TELETHERMOGRAPHIC SYSTEM I
  884.2982 LIQUID CRYSTAL THERMOGRAPHIC SYSTEM I
  884.4120 GYNECOLOGIC ELECTROCAUTERY AND ACCESSORIES II
  884.4550 GYNECOLOGIC SURGICAL LASER II
  884.5300 CONDOM II
  884.5310 CONDOM WITH SPERMICIDAL LUBRICANT II
  884.5460 SCENTED OR SCENTED DEODORIZED MENSTRUAL TAMPON II
  884.5470 UNSCENTED MENSTRUAL TAMPON 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
Ophthalmic
  886.1570 OPHTHALMOSCOPE - 2 CLASSES II
  886.1780 RETINOSCOPE II
  886.1850 AC-POWERED SLIT-LAMP BIOMICROSCOPE II
  886.3400 KERATOPROSTHESIS II
  886.4070 POWERED CORNEAL BURR I
  886.4150 VITREOUS ASPIRATION AND CUTTING INSTRUMENT II
  886.4300 INTRAOCULAR LENS GUIDE I
  886.4370 KERATOME I
  886.4390 OPHTHALMIC LASER II
  886.4392 ND:YAG LASER FOR POSTERIOR CAPSULOTOMY II
  886.4670 PHACOFRAGMENTATION SYSTEM II
  886.5916 RIGID GAS PERMEABLE CONTACT LENS II
  886.5918 RIGID GAS PERMEABLE CONTACT LENS CARE PRODUCTS II
  886.5925 SOFT (HYDROPHILIC) CONTACT LENS II
  886.5928 SOFT (HYDROPHYLIC) CONTACT LENS CARE PRODUCTS II
PanelSection Number       Regulation Name / Device Name      Class
Physical Medicine
  890.1385 DIAGNOSTIC ELECTROMYOGRAPH NEEDLE ELECTRODE 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
  890.5100 IMMERSION HYDROBATH II
  890.5500 INFRARED LAMP II
  890.5710 HOT OR COLD DISPOSABLE PACK I
  890.5850 POWERED MUSCLE STIMULATOR 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
  892.1200 EMISSION COMPUTED TOMOGRAPHY SYSTEM II
  892.1310 NUCLEAR TOMOGRAPHIC SYSTEM II
  892.1360 RADIONUCLIDE DOSE CALIBRATOR 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
  892.1670 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
  892.1740 TOMOGRAPHIC X-RAY SYSTEM II
  892.1750 COMPUTED TOMOGRAPHY X-RAY SYSTEM II
  892.1820 PNEUMOENCEPHALOGRAPHIC CHAIR II
  892.1850 RADIOGRAPHIC FILM CASSETTE II
  892.1870 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
PanelSection Number       Regulation Name / Device Name      Class
General & Plastic Surgery
  878.4400 ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES II
  878.4460 SURGEON'S GLOVES I
  878.4580 SURGICAL LAMP II
  878.4780 POWERED SUCTION PUMP II
  878.4810 LASER SURGICAL INSTRUMENT FOR USE IN GENERAL & PLASTIC SURGERY & IN DERMATOLOGY II
PanelSection Number       Regulation Name / Device Name      Class
Toxicology
  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
  862.3200 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
  862.3600 MERCURY TEST SYSTEM I
  862.3610 METHAMPHETAMINE TEST SYSTEM II
  862.3620 METHADONE TEST SYSTEM II
  862.3640 MORPHINE TEST SYSTEM II
  862.3650 OPIATE TEST SYSTEM II
  862.3750 QUININE TEST SYSTEM I
  862.3850 SULPHANIMIDE TEST SYSTEM I
  862.3870 CANNABINOID 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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