510(k) K080435 ยท CIG Diazo Colorimetry, Bilirubin
OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181
| Applicant | Olympus Life Science Research Europa GmbH (Europa), Center Valley PA, US |
| Decision | Substantially Equivalent, Sep 5, 2008 |
| Received | Feb 19, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080435
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.