# K891337: Thromboscreen Aptt Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Pacific Hemostasis
- Decided: Apr 21, 1989 after 42 days
- Product code: GFO (Activated Partial Thromboplastin)
- Device class: 2
- Regulation: 21 CFR 864.7925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K022021: Vital Scientific Aptt, Aptt & Quikcoag Aptt (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K891337
Methodology: https://510kreport.com/methodology