510(k) K892801 ยท CIG Diazo Colorimetry, Bilirubin
CLINISTAT TOTAL BILIRUBIN REAGENT TEST
| Applicant | Heraeus Kulzer, Inc., Elkhart IN, US |
| Decision | Substantially Equivalent, Aug 15, 1989 |
| Received | Apr 17, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K892801
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.