# K800826: Fibrinogen Screen

- Pathway: 510(k) (Traditional)
- Applicant: Pacific Hemostasis
- Decided: May 30, 1980 after 46 days
- Product code: KQJ (System, Fibrinogen Determination)
- Device class: 2
- Regulation: 21 CFR 864.7340
- 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
- K060968: Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride 0.02M; Fibrinogen Control-Normal, Low (2007), 0 descendants of its own

## Recalls of this device
- May 19, 2017 · Class II · Z-2762-2017: An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list 100651, lot 890199. While the kit performs acc
- May 19, 2017 · Class II · Z-2763-2017: An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list 100651, lot 890199. While the kit performs acc

Source page: https://510kreport.com/device/K800826
Methodology: https://510kreport.com/methodology