510(k) K913250 ยท GJS Test, Time, Prothrombin
ACS ULTRA-2 THROMBOPLASTIN
| Applicant | Analytical Control Systems, Inc., Fishers IN, US |
| Decision | Substantially Equivalent, Nov 27, 1991 |
| Received | Jul 22, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913250
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.