510(k) K030740 ยท GHH Fibrin Split Products
MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 1, 2003 |
| Received | Mar 10, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K030740
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.