510(k) K861095 ยท CIG Diazo Colorimetry, Bilirubin
BILIRUBIN ASSAY KIT (TOTAL), CATA. NUMBER 202-04
| Applicant | Diagnostic Chemicals, Ltd. (Usa), Charlottestown,Pei,Canada, CA |
| Decision | Substantially Equivalent, Apr 21, 1986 |
| Received | Mar 24, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861095
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.