510(k) K880397 ยท CIG Diazo Colorimetry, Bilirubin
DIRECT BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU.
| Applicant | Data Medical Associates, Inc., Arlington TX, US |
| Decision | Substantially Equivalent, Mar 15, 1988 |
| Received | Jan 29, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880397
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.