GGM · Class II · 21 CFR 864.8625

FDA Product Code GGM: Control, Hemoglobin

Leading manufacturers include Bio-Rad, Eurotrol B.V. and Boehringer Mannheim Corp..

15
Total
15
Cleared
60d
Avg days
1979
Since

FDA 510(k) Cleared Control, Hemoglobin Devices (Product Code GGM)

15 devices
1–15 of 15
Cleared Nov 15, 2019
HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High
K192842
Eurotrol B.V.
Hematology · 43d
Cleared Feb 01, 2019
HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High
K182744
Eurotrol B.V.
Hematology · 126d
Cleared Nov 09, 2005
LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4
K052838
Bio-Rad
Chemistry · 33d
Cleared Nov 29, 2000
LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET
K003030
Bio-Rad
Hematology · 62d
Cleared Jul 05, 1985
PRECINORM HB
K852136
Boehringer Mannheim Corp.
Hematology · 50d

About Product Code GGM - Regulatory Context