510(k) K062862 ยท KNK Acid, Uric, Uricase (Colorimetric)
OLYMPUS URIC ACID REAGENT, MODEL OSR6X98
| Applicant | Olympus America, Inc., Irving TX, US |
| Decision | Substantially Equivalent, Apr 6, 2007 |
| Received | Sep 25, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062862
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 24, 2018 | Beckman Coulter Inc. Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698. Terminated |
KNK | None listed |
| Apr 13, 2016 | Beckman Coulter Inc. Uric Acid, Catalog No. OSR6x98
Product Usage:Uric acid OSR6x98 is intended as a System reagent for the quantitative determination of Uric Acid in human serum, heparinized plasma and urine on Beckman Terminated |
KNK | None listed |
| Jan 28, 2015 | Beckman Coulter Inc. Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98 Terminated |
KNK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.