GIS · Class II · 21 CFR 864.7340

FDA Product Code GIS: Test, Fibrinogen

Leading manufacturers include R2 Diagnostics, Inc., Diazyme Laboratories and Pacific Hemostasis.

13
Total
13
Cleared
118d
Avg days
1978
Since

FDA 510(k) Cleared Test, Fibrinogen Devices (Product Code GIS)

13 devices
1–13 of 13
Cleared Jan 31, 2016
Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set
K143470
Diazyme Laboratories
Hematology · 422d
Cleared Nov 29, 2004
FIBROTEK FIB
K042919
R2 Diagnostics, Inc.
Hematology · 38d
Cleared Dec 06, 1999
K-ASSAY FIBRINOGEN
K993482
Kamiya Biomedical Co.
Hematology · 53d
Cleared Nov 29, 1996
QUANTITATIVE FIBRINOGEN ASSAY
K963902
Ortho Diagnostic Systems, Inc.
Hematology · 63d
Cleared Aug 30, 1994
ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT
K941001
Diagnostic Specialties
Hematology · 182d
Cleared May 18, 1993
BIOMERIEUX HEMOLAB FIBRINOMAT
K925494
Biomerieux Vitek, Inc.
Hematology · 197d
Cleared Oct 26, 1992
IL TEST PT FIBRINOGEN HS
K923921
Instrumentation Laboratory CO
Hematology · 82d
Cleared Oct 09, 1991
FIBRINOGEN DETERMINATION KIT
K913061
Sigma Diagnostics, Inc.
Hematology · 91d
Cleared Aug 09, 1988
FIBRINOGENTEST-O
K881685
Diatech, Inc.
Hematology · 112d
Cleared Mar 28, 1988
KINETIC FIBRINOGEN ASSAY
K881150
Bio/Data Corp.
Hematology · 11d
Cleared Dec 04, 1978
ASSAY KIT, THROMBO-SCREEN
K781880
Pacific Hemostasis
Hematology · 28d

About Product Code GIS - Regulatory Context