The following data is part of a premarket notification filed by Syva Co. with the FDA for Emit(r) Ii Benzodiazepine Assay.
| Device ID | K926067 |
| 510k Number | K926067 |
| Device Name: | EMIT(R) II BENZODIAZEPINE ASSAY |
| Classification | Enzyme Immunoassay, Benzodiazepine |
| Applicant | SYVA CO. 3403 YERBA BUENA RD. San Jose, CA 95135 -1500 |
| Contact | Paul L Rogers |
| Correspondent | Paul L Rogers SYVA CO. 3403 YERBA BUENA RD. San Jose, CA 95135 -1500 |
| Product Code | JXM |
| CFR Regulation Number | 862.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-01 |
| Decision Date | 1993-01-12 |