510(k) K050799 ยท GGN Plasma, Coagulation Control
TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS
| Applicant | Biosite Incorporated, San Diego CA, US |
| Decision | Substantially Equivalent, Jun 29, 2005 |
| Received | Mar 30, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050799
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.