510(k) K992665 ยท DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
MACRA LP(A) ENZYME IMMUNOASSAY KIT
| Applicant | Trinity Biotech USA, Jamestown NY, US |
| Decision | Substantially Equivalent, Nov 26, 1999 |
| Received | Aug 9, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992665
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.