The following data is part of a premarket notification filed by Syntron Bioresearch, Inc. with the FDA for Quickpac Ii One Step Opiates Test.
| Device ID | K993491 |
| 510k Number | K993491 |
| Device Name: | QUICKPAC II ONE STEP OPIATES TEST |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | SYNTRON BIORESEARCH, INC. 1420 LOS ANGELES AVE. SUITE 201 Simi Valley, CA 93065 |
| Contact | Cleve W Laird |
| Correspondent | James M Barquest CALIFORNIA DEPARTMENT OF HEALTH SERVICES P.O. BOX 942732 (MS-357) Sacramento, CA 94234 -7320 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 1999-10-15 |
| Decision Date | 1999-10-29 |
| Summary: | summary |