510(k) K863594 ยท GGW Test, Time, Partial Thromboplastin
ACTIN FSL ACTIVATED PTT REAGENT
| Applicant | American Dade, Santa Ana CA, US |
| Decision | Substantially Equivalent, Oct 17, 1986 |
| Received | Sep 15, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K863594
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 9, 2013 | Siemens Healthcare Diagnostics, Inc. Dade(R) Actin(R) FSL Activated PTT Reagent.
For use in the determination of the activated partial thromboplastin time (APTT). Terminated |
GGW | None listed |
| Feb 16, 2012 | Siemens Healthcare Diagnostics, Inc. Dade(R) Actin(R) FSL Activated PTT Reagent
Product Usage:
Liquid purified soy and rabbit brain phosphatides with plasma activator. An activated partial thromboplastin reagent with increased sensitiv Terminated |
GGW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.