The following data is part of a premarket notification filed by Syva Co. with the FDA for Syva Emit Ii Plus Ethyl Alcohol Assay, Models 9k309ul/9k409ul.
| Device ID | K993980 |
| 510k Number | K993980 |
| Device Name: | SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL |
| Classification | Nad-nadh, Specific Reagent For Alcohol Enzyme Method |
| Applicant | SYVA CO. 3403 YERBA BUENA RD. San Jose, CA 95161 -9013 |
| Contact | Paul L Rogers |
| Correspondent | Paul L Rogers SYVA CO. 3403 YERBA BUENA RD. San Jose, CA 95161 -9013 |
| Product Code | DML |
| CFR Regulation Number | 862.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-24 |
| Decision Date | 2000-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414569277 | K993980 | 000 |
| 00842768014413 | K993980 | 000 |
| 00842768002038 | K993980 | 000 |
| 00842768002021 | K993980 | 000 |