510(k) K030003 ยท CIG Diazo Colorimetry, Bilirubin
ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR
| Applicant | Elan Diagnostics, Brea CA, US |
| Decision | Substantially Equivalent, Sep 29, 2003 |
| Received | Jan 2, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030003
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.