The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Roche C0bas Integra Serum Barbiturates Reagent Cassette, Abuscreeb Online Serum Barbiturates Calibrators, Roche Cobas In.
| Device ID | K982551 |
| 510k Number | K982551 |
| Device Name: | ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE SERUM BARBITURATES CALIBRATORS, ROCHE COBAS IN |
| Classification | Enzyme Immunoassay, Barbiturate |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -1760 |
| Contact | Rita Smith |
| Correspondent | Rita Smith ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -1760 |
| Product Code | DIS |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | JXM |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-22 |
| Decision Date | 1998-08-18 |
| Summary: | summary |