510(k) K934361 ยท CGX Alkaline Picrate, Colorimetry, Creatinine
OLYMPUS CREATININE REAGENT
| Applicant | Olympus Corp., Lake Success NY, US |
| Decision | Substantially Equivalent, Nov 16, 1993 |
| Received | Sep 8, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934361
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2013 | Beckman Coulter Inc. Creatinine, Part Numbers OSR6178, OSR6678
Product Usage:
System reagent for the quantitative determination of Creatinine in human serum and urine on Beckman Coulter AU analyzers. Terminated |
CGX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.