# K072304: Fibrinogen Calibrator Kit

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Sep 19, 2007 after 33 days
- Product code: GFX (Fibrinogen Standard)
- 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 K925988 (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)
- K994341: Fibrinogen Calibrator Kit, Dade Behring, Inc. (2000) Summary page 1.

## Indications for use
Fibrinogen Calibrators 1 to 6 are used to prepare reference curves for the assay of fibrinogen by the method of Clauss using Dade Behring Multifibren TM U.

Source page: https://510kreport.com/device/K072304
Methodology: https://510kreport.com/methodology