510(k) K811589 ยท GGW Test, Time, Partial Thromboplastin
ACTIN FS ACTIVATED PTT REAGENT
| Applicant | American Dade, Walker MI, US |
| Decision | Substantially Equivalent, Jul 16, 1981 |
| Received | Jun 8, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811589
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2005 | Dade Behring , Inc. Dade Actin FS Activated PTT Reagent. Reagent and Control Partial Thromboplastin Time. Catalog number B4218-100 Terminated |
GGW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.