The following data is part of a premarket notification filed by Syntron Bioresearch, Inc. with the FDA for Quickpac Ii One Step Barbiturate Test.
| Device ID | K980349 |
| 510k Number | K980349 |
| Device Name: | QUICKPAC II ONE STEP BARBITURATE TEST |
| Classification | Enzyme Immunoassay, Barbiturate |
| Applicant | SYNTRON BIORESEARCH, INC. 1420 LOS ANGELES AVE. SUITE 201 Simi Valley, CA 93065 |
| Contact | Cleve W Laird |
| Correspondent | Cleve W Laird SYNTRON BIORESEARCH, INC. 1420 LOS ANGELES AVE. SUITE 201 Simi Valley, CA 93065 |
| Product Code | DIS |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-28 |
| Decision Date | 1998-03-03 |
| Summary: | summary |