510(k) K002706 ยท DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 16, 2001 |
| Received | Aug 30, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002706
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.