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GGM — Control, Hemoglobin Class II

FDA Device Classification

Classification Details

Product Code
GGM
Device Class
Class II
Regulation Number
864.8625
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K192842eurotrolHemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo HighNovember 15, 2019
K182744eurotrolHemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - HighFebruary 1, 2019
K070546bio-rad laboratoriesLYPHOCHEK DIABETES CONTROLApril 2, 2007
K070334r and d systemsR&D SICKLE QC CONTROLMarch 29, 2007
K052838bio-radLIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4November 9, 2005
K032791quantimetrixGLYCOHEMOSURE HBA1C CONTROLOctober 30, 2003
K003030bio-radLYPHOCHEK HEMOGLOBIN ALC LINEARITY SETNovember 29, 2000
K993321r and d systemsR&D HGB/GLC WHOLE BLOOD CONTROLNovember 12, 1999
K964052direct solutionsHEMOCUE HEMOTROLNovember 6, 1996
K963908direct solutionsHEMOCUE HEMOLINOctober 16, 1996
K921681isolabCRITERION, HEMOCUE B-HEMOGLOBIN CONTROLNovember 17, 1992
K893985r and d systemsHGB-CONTROL SET/MULTIPLEAugust 15, 1989
K852136boehringer mannheimPRECINORM HBJuly 5, 1985
K800296dade, baxter travenol diagnosticsWHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3March 5, 1980
K790310electrophoresisHEMOGLOBIN CONTROLSMarch 21, 1979