510(k) K981632 ยท CIG Diazo Colorimetry, Bilirubin
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT
| Applicant | Roche Diagnostics/Boehringer Mannheim GmbH, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jun 15, 1998 |
| Received | May 8, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981632
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.