510(k) K012768 ยท GJS Test, Time, Prothrombin
HEMOSIL RECOMBI PLASTIN
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Sep 18, 2001 |
| Received | Aug 17, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012768
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.