510(k) K924396 ยท GJT Plasma, Coagulation Factor Deficient
CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA
| Applicant | Behring Diagnostics, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, May 21, 1993 |
| Received | Aug 31, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K924396
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2015 | Siemens Healthcare Diagnostics, Inc. Factor deficient plasma for the Siemens BCS / BCS XP System.
In vitro diagnostic reagent for the determination of the activity of coagulation factor IX in human plasma by coagulometric methods. Terminated |
GJT | None listed |
| Aug 16, 2005 | Dade Behring , Inc. Coagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency Test Terminated |
GJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.