510(k) K050266 ยท JFM Enzymatic Method, Bilirubin
DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR
| Applicant | Stanbio Laboratory, Boerne TX, US |
| Decision | Substantially Equivalent, Jun 30, 2005 |
| Received | Feb 4, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050266
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.