# K924396: Clotting Factor-Viii-IX-XI-Xii Deficient Plasma

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: May 21, 1993 after 263 days
- Product code: GJT (Plasma, Coagulation Factor Deficient)
- Device class: 2
- Regulation: 21 CFR 864.7290
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K961929: Factor Deficient Plasma (1996), 0 descendants of its own

## Recalls of this device
- May 11, 2015 · Class II · Z-1713-2015: Discrepancies for Siemens BCS / BCS XP with dilution studies; erroneously high Factor IX results at the lower end of the measuring range.
- Jul 8, 2005 · Not classified · Z-1374-05: sample may exhibit falsely high results

Source page: https://510kreport.com/device/K924396
Methodology: https://510kreport.com/methodology