GIS · Class II · 21 CFR 864.7340

FDA Product Code GIS: Test, Fibrinogen

Leading manufacturers include Diazyme Laboratories.

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

About Product Code GIS - Regulatory Context

GIS devices are reviewed by the Hematology panel. Browse all Hematology devices →