The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Cobas Integra Reagent Cassettes & Ancillary Reagents.
| Device ID | K963292 |
| 510k Number | K963292 |
| Device Name: | COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS |
| Classification | Cresolphthalein Complexone, Calcium |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
| Contact | Andrea Casper |
| Correspondent | Andrea Casper ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
| Product Code | CIC |
| Subsequent Product Code | DBF |
| Subsequent Product Code | DDQ |
| Subsequent Product Code | DDR |
| Subsequent Product Code | DHR |
| Subsequent Product Code | JBQ |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-21 |
| Decision Date | 1996-10-31 |
| Summary: | summary |