510(k) K945078 ยท GJS Test, Time, Prothrombin
HEMOCHRON HNPT/FACTOR VI PT+
| Applicant | International Technidyne Corp., Edison NJ, US |
| Decision | Substantially Equivalent, Apr 28, 1995 |
| Received | Oct 17, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945078
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.