GGM · Class II · 21 CFR 864.8625

FDA Product Code GGM: Control, Hemoglobin

Leading manufacturers include R&D Systems, Inc., Direct Solutions and Bio-Rad.

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 Apr 02, 2007
LYPHOCHEK DIABETES CONTROL
K070546
Bio-Rad Laboratories
Chemistry · 35d
Cleared Mar 29, 2007
R&D SICKLE QC CONTROL
K070334
R&D Systems, Inc.
Hematology · 52d
Cleared Nov 09, 2005
LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4
K052838
Bio-Rad
Chemistry · 33d
Cleared Oct 30, 2003
GLYCOHEMOSURE HBA1C CONTROL
K032791
Quantimetrix Corp.
Chemistry · 52d
Cleared Nov 29, 2000
LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET
K003030
Bio-Rad
Hematology · 62d
Cleared Nov 12, 1999
R&D HGB/GLC WHOLE BLOOD CONTROL
K993321
R&D Systems, Inc.
Hematology · 39d
Cleared Nov 06, 1996
HEMOCUE HEMOTROL
K964052
Direct Solutions
Hematology · 37d
Cleared Oct 16, 1996
HEMOCUE HEMOLIN
K963908
Direct Solutions
Hematology · 16d
Cleared Nov 17, 1992
CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL
K921681
Isolab, Inc.
Hematology · 223d
Cleared Aug 15, 1989
HGB-CONTROL SET/MULTIPLE
K893985
R&D Systems, Inc.
Hematology · 71d
Cleared Jul 05, 1985
PRECINORM HB
K852136
Boehringer Mannheim Corp.
Hematology · 50d
Cleared Mar 05, 1980
WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3
K800296
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 23d
Cleared Mar 21, 1979
HEMOGLOBIN CONTROLS
K790310
Electrophoresis Corp.
Hematology · 36d

About Product Code GGM - Regulatory Context