GIS · Class II · 21 CFR 864.7340

FDA Product Code GIS: Test, Fibrinogen

Leading manufacturers include Diazyme Laboratories, Sigma Diagnostics, Inc. and Instrumentation Laboratory CO.

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, 1996
QUANTITATIVE FIBRINOGEN ASSAY
K963902
Ortho Diagnostic Systems, Inc.
Hematology · 63d
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

About Product Code GIS - Regulatory Context