510(k) K010193 ยท KFF Assay, Heparin
HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS
| Applicant | International Technidyne Corp., Edison NJ, US |
| Decision | Substantially Equivalent, Jun 6, 2001 |
| Received | Jan 22, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010193
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.