510(k) K990595 ยท DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 14, 1999 |
| Received | Feb 24, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990595
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.