510(k) K945940 ยท GGW Test, Time, Partial Thromboplastin
COATEST(R) APC(TM) RESISTANCE
| Applicant | Axis-Shield Doc AS, San Diego CA, US |
| Decision | Substantially Equivalent, Aug 7, 1995 |
| Received | Dec 5, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945940
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.