510(k) K892905 ยท CIG Diazo Colorimetry, Bilirubin
DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI.
| Applicant | Catachem, Inc., Port Chester NY, US |
| Decision | Substantially Equivalent, Jun 19, 1989 |
| Received | Apr 20, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K892905
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.