The following data is part of a premarket notification filed by Syntron Bioresearch, Inc. with the FDA for Quickpac Ii One Step Cocaine Test.
| Device ID | K992990 |
| 510k Number | K992990 |
| Device Name: | QUICKPAC II ONE STEP COCAINE TEST |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | SYNTRON BIORESEARCH, INC. 1420 LOS ANGELES AVE. SUITE 201 Simi Valley, CA 93065 |
| Contact | Cleve W Laird |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 1999-09-07 |
| Decision Date | 1999-09-20 |
| Summary: | summary |