The following data is part of a premarket notification filed by Syva Co. with the FDA for Emit(r) Iic Opiate Assay.
| Device ID | K935117 |
| 510k Number | K935117 |
| Device Name: | EMIT(R) IIC OPIATE ASSAY |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | SYVA CO. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013 |
| Contact | Paul Rogers |
| Correspondent | Paul Rogers SYVA CO. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-27 |
| Decision Date | 1994-01-06 |