The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Roche Cobas Integra Reagent Cassettes.
| Device ID | K954992 |
| 510k Number | K954992 |
| Device Name: | ROCHE COBAS INTEGRA REAGENT CASSETTES |
| Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -3771 |
| Contact | Maria Feijoo |
| Correspondent | Maria Feijoo ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -3771 |
| Product Code | CIT |
| Subsequent Product Code | CFJ |
| Subsequent Product Code | CFR |
| Subsequent Product Code | CKA |
| Subsequent Product Code | DAD |
| Subsequent Product Code | DCF |
| Subsequent Product Code | DEM |
| Subsequent Product Code | DIF |
| Subsequent Product Code | DKJ |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | GTQ |
| Subsequent Product Code | JGJ |
| Subsequent Product Code | JHN |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JIY |
| Subsequent Product Code | JJY |
| Subsequent Product Code | JXN |
| Subsequent Product Code | KHS |
| Subsequent Product Code | KLP |
| Subsequent Product Code | &nb |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-31 |
| Decision Date | 1996-01-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336121504 | K954992 | 000 |
| 04015630926992 | K954992 | 000 |
| 04015630915828 | K954992 | 000 |
| 04015630913381 | K954992 | 000 |