510(k) K024098 ยท JFY Enzymatic Method, Creatinine
COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 19, 2002 |
| Received | Dec 12, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K024098
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 14, 2018 | Roche Diagnostics Corporation cobas c 111 with ISE analyzers analyzer used in the following assays:
a)Creatinine plus ver.2
Catalog Number: 05401470190;
b)Triglycerides
Catalog Number: 04657594190 - Product Usage: Tina-quant Ap Terminated |
JJE | None listed |
| Oct 9, 2008 | Roche Diagnostics Corp. Roche Diagnostics CREP2, Creatinine Plus Ver. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03263991190.
An in-vitro diagnostic reagent system intended for use on COBAS Int Terminated |
JFY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.