# K970593: Universal Reagent Factor Viii Deficient Plasma

- Pathway: 510(k) (Traditional)
- Applicant: Universal Reagents, Inc.
- Decided: Apr 25, 1997 after 66 days
- Product code: GJT (Plasma, Coagulation Factor Deficient)
- 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 K823453 (1983). 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)
- K823453: Von Willebrand Factor Assay, General Diagnostics (1983) Summary page 1.

## Indications for use
Factor deficient plasma, Factor - VII 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/K970593
Methodology: https://510kreport.com/methodology