GIL · Class II · 21 CFR 864.7340

FDA Product Code GIL: Plasma, Fibrinogen Control

Leading manufacturers include Behring Diagnostics, Inc., Warner-Lambert Co. and Sigma Diagnostics, Inc..

8
Total
8
Cleared
196d
Avg days
1983
Since

FDA 510(k) Cleared Plasma, Fibrinogen Control Devices (Product Code GIL)

8 devices
1–8 of 8
Cleared Jul 29, 1996
N/T PROTEIN CONTROL PY
K962407
Behring Diagnostics, Inc.
Hematology · 38d
Cleared Apr 17, 1995
N/T PROTEIN CONTROL PY
K951012
Behring Diagnostics, Inc.
Hematology · 42d
Cleared Mar 04, 1992
FIBRINOGEN CONTROL
K915462
Sigma Diagnostics, Inc.
Hematology · 91d
Cleared Nov 03, 1983
GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL
K833352
Warner-Lambert Co.
Hematology · 36d

About Product Code GIL - Regulatory Context