Recognized Consensus Standards

510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA

New Search Back To Search Results Recognition List Number: 016 Publication Date: 11/03/2006  Part B: SUPPLEMENTARY INFORMATION Recognition Number 7-48: CLSI / NCCLS T/DM06-A, Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline (1997). (InVitro Diagnostics) Date of Standard: 1997.  Addresses of Standards Organizations:   CLINICAL LABORATORY STANDARDS INSTITUTE (CLSI)   940 WEST VALLEY ROAD   SUITE 1400   WAYNE, PA 19087     NATIONAL COMMITTEE FOR CLINICAL LABORATORY STANDARDS (NCCLS)   940 WEST VALLEY ROAD   SUITE 1400   WAYNE, PA 19087   CDRH Office and Division Associated with Recognized Standards: OFFICE OF DEVICE EVALUATION (ODE) DIVISION OF CLINICAL LABORATORY DEVICES (DCLD) Devices Affected: Blood Alcohol Testing Processes Affected: 510(k) Type of Standard:  National, Vertical Extent of Recognition: Complete standard Related CFR Citations and Product Codes: Regulation Number Device Name Device Class Product Code §862.1145 Cresolphthalein Complexone, Calcium Class 2 CIC   Regulation Number Device Name Device Class Product Code §862.3040 Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet Class 2 DMT §862.3040 Potassium Dichromate Specific Reagent For Alcohol Class 2 DMI §862.3040 Potassium Dichromate, Alcohol Class 2 DOJ   Relevant Guidance: Points to Consider for Collection of Data in Support of In Vitro Device Submissions for 510(k) Clearance FDA Technical Contact:   Douglas Rheinheimer   FDA/CDRH/OIVD/DCTD   2098 Gaither Road, HFZ-440   Rockville MD 20850   240/276-0496 ext: 103   Email: douglas.rheinheimer@fda.hhs.gov