# K251968: HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL

- Pathway: 510(k) (Special)
- Applicant: Instrumentation Laboratory (IL) Co.
- Decided: Jul 24, 2025 after 28 days
- Product code: KQJ (System, Fibrinogen Determination)
- 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
Longest line of descent: 2 generations back to K931721 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073367: Hemosil Fibrinogen-C, Instrumentation Laboratory CO (2007) Summary page 4.

## Indications for use
For the quantitative determination of fibrinogen, based on the Clauss method, in human citrated plasma on IL Coagulation Systems.

Source page: https://510kreport.com/device/K251968
Methodology: https://510kreport.com/methodology