510(k) K760318 ยท GFO Activated Partial Thromboplastin
ACTIN, ACTIVATED CEPHALOPLASTIN REAGENT
| Applicant | Dade, Baxter Travenol Diagnostics, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 3, 1976 |
| Received | Jul 26, 1976 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K760318
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2015 | Siemens Healthcare Diagnostics, Inc. Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in the determination of the activated partial thromboplastin time (APTT) and other coagulation p Terminated |
GFO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.