# K994341: Fibrinogen Calibrator Kit

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Mar 3, 2000 after 71 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: 1 generation back to K925988 (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)
- K925988: Multifibren, Behring Diagnostics, Inc. (1993) Summary page 1.

## Most influential descendants
- K072304: Fibrinogen Calibrator Kit (2007), 0 descendants of its own

## 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 Multifibrin U.

Source page: https://510kreport.com/device/K994341
Methodology: https://510kreport.com/methodology