The following data is part of a premarket notification filed by Enzymatics C/o Burditt,bowles,radzius & Ruberry with the FDA for Saliva Alcohol Test.
| Device ID | K894001 |
| 510k Number | K894001 |
| Device Name: | 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 | Christopher Zalesky |
| Correspondent | Christopher 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 | 1989-06-05 |
| Decision Date | 1990-04-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20608337150302 | K894001 | 000 |