510(k) K915344 ยท GFO Activated Partial Thromboplastin
HEMOCHRON ONESTEP APTT TEST
| Applicant | International Technidyne Corp., Edison NJ, US |
| Decision | Substantially Equivalent, Feb 11, 1992 |
| Received | Nov 26, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915344
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.