# K984129: Coagulation Control Level 1 (Normal)

- Pathway: 510(k) (Traditional)
- Applicant: Pacific Hemostasis
- Decided: Dec 1, 1998 after 13 days
- Product code: GIZ (Plasma, Control, Normal)
- 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
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. The FDA summary names its predicate without a number.
- (no number) Dade Ci-Trol Coagulation Control Level 1: named in the summary without a submission number

## 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 Normal, Level 1, is intended for use as a control to monitor the performance of three routine coagulation assays: Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), and fibrinogen concentration in the normal range.

Source page: https://510kreport.com/device/K984129
Methodology: https://510kreport.com/methodology