510(k) K972316 ยท GHH Fibrin Split Products
OPUS D-DIMER
| Applicant | Behring Diagnostics, Inc., Westwood MA, US |
| Decision | Substantially Equivalent, Sep 9, 1997 |
| Received | Jun 20, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972316
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.