510(k) K981883 ยท CIG Diazo Colorimetry, Bilirubin
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 7, 1998 |
| Received | May 29, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981883
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.