510(k) K881999 ยท GIT Reagent & Control, Partial Thromboplastin Time
PLATELIN(R) EXCEL L
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, Aug 17, 1988 |
| Received | May 12, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K881999
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.