510(k) K892209 ยท GFO Activated Partial Thromboplastin
APTT BY HEMOCHRON(R)
| Applicant | Intensive Technology, Inc., Edison NJ, US |
| Decision | Substantially Equivalent, Jun 22, 1989 |
| Received | Apr 3, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K892209
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.