510(k) K961892 ยท GFO Activated Partial Thromboplastin
SPECKTIN-LA TEST SET
| Applicant | Analytical Control Systems, Inc., Fishers IN, US |
| Decision | Substantially Equivalent, Mar 7, 1997 |
| Received | May 16, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961892
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.