The following data is part of a premarket notification filed by Syva Co. with the FDA for Emit(r) D.a.u. Benzodiazepine Assay.
| Device ID | K931536 |
| 510k Number | K931536 |
| Device Name: | EMIT(R) D.A.U. BENZODIAZEPINE ASSAY |
| Classification | Enzyme Immunoassay, Benzodiazepine |
| Applicant | SYVA CO. P.O. BOX 49013 San Jose, CA 95161 -9013 |
| Contact | Paul L Rogers |
| Correspondent | Paul L Rogers SYVA CO. 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 | 1993-03-29 |
| Decision Date | 1993-05-11 |