# K984131: Coagulation Control Level 3 (Abnormal)

- Pathway: 510(k) (Traditional)
- Applicant: Pacific Hemostasis
- Decided: Dec 1, 1998 after 13 days
- Product code: GGC (Control, Plasma, Abnormal)
- Device class: 2
- Regulation: 21 CFR 864.5425
- 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 K771346 (1977). 1 ancestor in all.
1 later device descends from it; 1 cites 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)
- K771346: CI-Trol Coagulation Controls II & Iii, Dade, Baxter Travenol Diagnostics, Inc. (1977) Summary page 1.

## 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

## Indications for use
Pacific Hemostasis Coagulation Control, Abnormal, Level 3, is intended for use as a control to monitor the performance of two routine coagulation assays: Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT), in the markedly abnormal range.

Source page: https://510kreport.com/device/K984131
Methodology: https://510kreport.com/methodology