# K964270: Universal Reagent Factor V Deficient Plasma

- Pathway: 510(k) (Traditional)
- Applicant: Universal Reagents, Inc.
- Decided: Dec 18, 1996 after 54 days
- Product code: GGP (Test, Qualitative And Quantitative Factor Deficiency)
- Device class: 2
- Regulation: 21 CFR 864.7290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K792507 (1979). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K792507: Helena Factor V Deficient Substrate, Helena Laboratories (1979) Summary page 1.

## Indications for use
Factor deficient plasma, Factor - V is a human plasma immunodepleted of the specific factor and intended for use in the quantitative determination of the specific factor levels in patients suspected of congenital or acquired deficiency of this specific coagulation protein and is performed by clotting assay.

Source page: https://510kreport.com/device/K964270
Methodology: https://510kreport.com/methodology