The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Roche Cobas Ibtegra Reagent Cassettes.
| Device ID | K964457 |
| 510k Number | K964457 |
| Device Name: | ROCHE COBAS IBTEGRA REAGENT CASSETTES |
| Classification | Kinetic Method, Gamma-glutamyl Transpeptidase |
| 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 | JQB |
| Subsequent Product Code | CEK |
| Subsequent Product Code | CFJ |
| Subsequent Product Code | CFN |
| Subsequent Product Code | KHP |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-06 |
| Decision Date | 1997-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336121368 | K964457 | 000 |
| 07613336121351 | K964457 | 000 |
| 04015630926961 | K964457 | 000 |
| 04015630925056 | K964457 | 000 |
| 04015630922246 | K964457 | 000 |
| 04015630922222 | K964457 | 000 |
| 04015630916337 | K964457 | 000 |
| 04015630916276 | K964457 | 000 |