The following data is part of a premarket notification filed by Syva Co. with the FDA for Syva Emit Ii Plus Barbiturate Assay, Model 9d029ul/9d129ul.
| Device ID | K993987 |
| 510k Number | K993987 |
| Device Name: | SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL |
| Classification | Enzyme Immunoassay, Carbamazepine |
| 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 | KLT |
| CFR Regulation Number | 862.3645 [🔎] |
| 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 |
|---|---|---|
| 00842768014352 | K993987 | 000 |
| 00842768001888 | K993987 | 000 |
| 00842768001871 | K993987 | 000 |