Control, Hemoglobin

FDA product code GGM · Class II (moderate risk) · 21 CFR 864.8625 · Hematology

15510(k) clearances
0PMA approvals
2recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K192842HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo HighGGM · Traditional Eurotrol B.V.11/15/2019SE
K182744HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - HighGGM · Traditional Eurotrol B.V.02/01/2019SE
K070546Lyphochek Diabetes ControlGGM · Traditional Bio-Rad Laboratories04/02/2007SE
K070334R&D Sickle QC ControlGGM · Traditional R&D Systems, Inc.03/29/2007SE
K052838Liquichek Diabetes Control, Level 1,2,3,4GGM · Traditional Bio-Rad11/09/2005SE
K032791Glycohemosure HBA1C ControlGGM · Traditional Quantimetrix Corp.10/30/2003SE
K003030Lyphochek Hemoglobin Alc Linearity SetGGM · Traditional Bio-Rad11/29/2000SE
K993321R&D Hgb/Glc Whole Blood ControlGGM · Traditional R&D Systems, Inc.11/12/1999SE
K964052Hemocue HemotrolGGM · Traditional Direct Solutions11/06/1996SE
K963908Hemocue HemolinGGM · Traditional Direct Solutions10/16/1996SE
K921681Criterion, Hemocue B-Hemoglobin ControlGGM · Traditional Isolab, Inc.11/17/1992SE
K893985Hgb-Control Set/MultipleGGM · Traditional R&D Systems, Inc.08/15/1989SE
K852136Precinorm HBGGM · Traditional Boehringer Mannheim Corp.07/05/1985SE
K800296Whole Blood Gas Control, Levels 1,2,&3GGM · Traditional Dade, Baxter Travenol Diagnostics, Inc.03/05/1980SE
K790310Hemoglobin ControlsGGM · Traditional Electrophoresis Corp.03/21/1979SE

Recalls

RecallProductFirmInitiated
Z-0515-2019 Class IIHemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture. Catalogue…Incorrect measurement results caused by microbial contamination of the product, results in values lower than… Eurotrol Inc10/18/2018Terminated
Z-0514-2019 Class IIHemoTrol Level 2- In Vitro Diagnostic Hematology quality control mixture Catalogue…Incorrect measurement results caused by microbial contamination of the product, results in values lower than… Eurotrol Inc10/18/2018Terminated