510(k) K003261 ยท JFY Enzymatic Method, Creatinine
CREATININE PLUS
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Nov 16, 2000 |
| Received | Oct 18, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K003261
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2015 | Roche Diagnostics Operations, Inc. Creatinine Plus ver. 2.
Intended for use on COBAS INTEGRA systems , cobas c111, and cobas c systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine. Terminated |
JFY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.