# K993482: K-Assay Fibrinogen

- Pathway: 510(k) (Traditional)
- Applicant: Kamiya Biomedical Co.
- Decided: Dec 6, 1999 after 53 days
- Product code: GIS (Test, Fibrinogen)
- Device class: 2
- Regulation: 21 CFR 864.7340
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K143470: Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set (2016), 0 descendants of its own

## Indications for use
The K-ASSAY Fibrinogen Assay is intended to be used to determine the fibrinogen levels in disseminated intravascular coagulation (non-localized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrinogen in a blood clot.) FOR IN VITRO DIAGNOSTIC USE.

Source page: https://510kreport.com/device/K993482
Methodology: https://510kreport.com/methodology