510(k) K013278 ยท DEL Lipoprotein X, Antigen, Antiserum, Control
TINA-QUANT APOLIPOPROTEIN A-1 VER.2
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Nov 15, 2001 |
| Received | Oct 1, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013278
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.