510(k) K961938 ยท GJS Test, Time, Prothrombin
STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS
| Applicant | Nova Biomedical Corp., Walham MA, US |
| Decision | Substantially Equivalent, Jun 28, 1996 |
| Received | May 20, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961938
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.