510(k) K981609 ยท CIG Diazo Colorimetry, Bilirubin
BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30
| Applicant | Diagnostic Chemicals , Ltd., Charlottestown,Pei,Canada, CA |
| Decision | Substantially Equivalent, Jun 3, 1998 |
| Received | May 5, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981609
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.