510(k) K070453 ยท GHH Fibrin Split Products
OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL
| Applicant | Olympus Life & Material Science Europa GmbH (Irish, Irving TX, US |
| Decision | Substantially Equivalent, Jun 11, 2007 |
| Received | Feb 16, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070453
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.