510(k) K050817 ยท GJA Test, Thrombin Time
T-TEK
| Applicant | R2 Diagnostics, Inc., South Bend IN, US |
| Decision | Substantially Equivalent, Dec 12, 2005 |
| Received | Mar 31, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050817
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.