510(k) K053090 ยท JFM Enzymatic Method, Bilirubin
DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Dec 16, 2005 |
| Received | Nov 2, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053090
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.