The following data is part of a premarket notification filed by Syva Co. with the FDA for Syva Emit Ii Plus Benzodiazepine Assay, Models 9f029ul/9f129ul.
| Device ID | K993985 |
| 510k Number | K993985 |
| Device Name: | SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL |
| Classification | Enzyme Immunoassay, Benzodiazepine |
| Applicant | SYVA CO. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013 |
| Contact | Paul L Rogers |
| Correspondent | Paul L Rogers SYVA CO. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013 |
| Product Code | JXM |
| CFR Regulation Number | 862.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-24 |
| Decision Date | 2000-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414596075 | K993985 | 000 |
| 00630414568768 | K993985 | 000 |
| 00842768014376 | K993985 | 000 |
| 00842768001901 | K993985 | 000 |
| 00842768001895 | K993985 | 000 |