FDA 510(k) Applications for Medical Device Product Code: GGM (Control, Hemoglobin)

FDA 510(k) Applications for Medical Device Product Code "GGM"
(Control, Hemoglobin)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K052838	BIO-RAD	LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4	11/09/2005
K003030	BIO-RAD	LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET	11/29/2000
K070546	Bio-Rad Laboratories	LYPHOCHEK DIABETES CONTROL	04/02/2007
K963908	DIRECT SOLUTIONS	HEMOCUE HEMOLIN	10/16/1996
K964052	DIRECT SOLUTIONS	HEMOCUE HEMOTROL	11/06/1996
K192842	Eurotrol B.V.	HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High	11/15/2019
K182744	EUROTROL B.V.	HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High	02/01/2019
K032791	QUANTIMETRIX CORP.	GLYCOHEMOSURE HBA1C CONTROL	10/30/2003
K993321	R & D SYSTEMS, INC.	R&D HGB/GLC WHOLE BLOOD CONTROL	11/12/1999
K070334	R & D SYSTEMS, INC.	R&D SICKLE QC CONTROL	03/29/2007