The following data is part of a premarket notification filed by Enzymatics C/o Burditt,bowles,radzius & Ruberry with the FDA for Statlab A-350 Saliva Alcohol Test.
Device ID | K903235 |
510k Number | K903235 |
Device Name: | STATLAB A-350 SALIVA ALCOHOL TEST |
Classification | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method |
Applicant | ENZYMATICS C/O BURDITT,BOWLES,RADZIUS & RUBERRY 355 BUSINESS CENTER DR. Horsham, PA 19044 |
Contact | Christoper Zalesky |
Correspondent | Christoper Zalesky ENZYMATICS C/O BURDITT,BOWLES,RADZIUS & RUBERRY 355 BUSINESS CENTER DR. Horsham, PA 19044 |
Product Code | DIC |
CFR Regulation Number | 862.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-23 |
Decision Date | 1990-10-12 |