510(k) K112120 ยท GHH Fibrin Split Products
DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET
| Applicant | Diazyme Laboratories, Poway CA, US |
| Decision | Substantially Equivalent, Jan 24, 2013 |
| Received | Jul 25, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112120
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.