510(k) K991175 ยท CIG Diazo Colorimetry, Bilirubin
MODIFICATION TO ALCYON DIRECT BILIRUBIN
| Applicant | Abbott Laboratories, Irving TX, US |
| Decision | Substantially Equivalent, May 28, 1999 |
| Received | Mar 29, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991175
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.