510(k) K964457 ยท JQB Kinetic Method, Gamma-Glutamyl Transpeptidase
ROCHE COBAS IBTEGRA REAGENT CASSETTES
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Jan 13, 1997 |
| Received | Nov 6, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964457
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 13, 2019 | Roche Diagnostics Corporation Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190,
***added as of 5/10/19*** 03183700190
Product Usage:
An In vitro diagnostic reagent system intended for use on cobas Integra for t Terminated |
KHP | None listed |
| Jun 27, 2015 | Roche Diagnostics Operations, Inc. Lactate.
Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems for the quantitative determination of lactate concentration in plas Terminated |
CFJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.