GFX · Class II · 21 CFR 864.7340

FDA Product Code GFX: Fibrinogen Standard

Leading manufacturers include Dade Behring, Inc. and E.I. Dupont DE Nemours & Co., Inc..

3
Total
3
Cleared
58d
Avg days
1981
Since

FDA 510(k) Cleared Fibrinogen Standard Devices (Product Code GFX)

3 devices
1–3 of 3
Cleared Sep 19, 2007
FIBRINOGEN CALIBRATOR KIT
K072304
Dade Behring, Inc.
Hematology · 33d
Cleared Mar 03, 2000
FIBRINOGEN CALIBRATOR KIT
K994341
Dade Behring, Inc.
Hematology · 71d
Cleared Nov 24, 1981
ACA FIBRINOGEN CALIBRATOR
K812628
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 70d

About Product Code GFX - Regulatory Context