510(k) K011143 ยท GHH Fibrin Split Products
TINA-QUANT D-DIMER TEST SYSTEM
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, May 29, 2001 |
| Received | Apr 13, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011143
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.