The following data is part of a premarket notification filed by Syva Co. with the FDA for Modification Of Emit D.a.u. Opiates Assay.
| Device ID | K984232 |
| 510k Number | K984232 |
| Device Name: | MODIFICATION OF EMIT D.A.U. OPIATES ASSAY |
| Classification | Enzyme Immunoassay, Opiates |
| 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 | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-25 |
| Decision Date | 1999-01-22 |
| Summary: | summary |