The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Cobas Integra Reagent Cassettes.
| Device ID | K982382 |
| 510k Number | K982382 |
| Device Name: | COBAS INTEGRA REAGENT CASSETTES |
| Classification | Method, Nephelometric, Immunoglobulins (g, A, M) |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
| Contact | Rita Smith |
| Correspondent | Rita Smith ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
| Product Code | CFN |
| Subsequent Product Code | CZP |
| Subsequent Product Code | DAH |
| Subsequent Product Code | DEM |
| Subsequent Product Code | DEW |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-08 |
| Decision Date | 1998-09-28 |
| Summary: | summary |