# K073367: Hemosil Fibrinogen-C

- Pathway: 510(k) (Special)
- Applicant: Instrumentation Laboratory CO
- Decided: Dec 27, 2007 after 27 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: 1 generation back to K931721 (1993). 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)
- K931721: IL Test Fibrinogen-C, Instrumentation Laboratory CO (1993) Summary page 1.

## Most influential descendants
- K251968: HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL (2025), 0 descendants of its own

## Indications for use
HemosIL Fibrinogen-C is intended for the quantitative determination of fibrinogen, based on the Clauss method, in human citrated plasma on IL Coagulation Systems. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K073367
Methodology: https://510kreport.com/methodology