510(k) K955880 ยท CIG Diazo Colorimetry, Bilirubin
DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05
| Applicant | Diagnostic Chemicals , Ltd., Charlottetown, P.E.I., CA |
| Decision | Substantially Equivalent, Aug 27, 1996 |
| Received | Dec 28, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955880
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.