Atlas FDA

GGM

15 FDA 510(k) clearances · Product code

43 daysmedian time to decision
126 days90th percentile
15clearances measured

FDA profile

Official device name
Control, Hemoglobin
Device class
Class II (moderate risk)
Regulation
21 CFR 864.8625
Medical specialty
Hematology
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RecordFirmDate
HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High (K192842)Eurotrol B.V.2019-11-15
HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High (K182744)Eurotrol B.V.2019-02-01
LYPHOCHEK DIABETES CONTROL (K070546)Bio-Rad Laboratories2007-04-02
R&D SICKLE QC CONTROL (K070334)R&D Systems, Inc.2007-03-29
LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 (K052838)Bio-Rad2005-11-09
GLYCOHEMOSURE HBA1C CONTROL (K032791)Quantimetrix Corp.2003-10-30
LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET (K003030)Bio-Rad2000-11-29
R&D HGB/GLC WHOLE BLOOD CONTROL (K993321)R&D Systems, Inc.1999-11-12
HEMOCUE HEMOTROL (K964052)Direct Solutions1996-11-06
HEMOCUE HEMOLIN (K963908)Direct Solutions1996-10-16
CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL (K921681)Isolab, Inc.1992-11-17
HGB-CONTROL SET/MULTIPLE (K893985)R&D Systems, Inc.1989-08-15
PRECINORM HB (K852136)Boehringer Mannheim Corp.1985-07-05
WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3 (K800296)Dade, Baxter Travenol Diagnostics, Inc.1980-03-05
HEMOGLOBIN CONTROLS (K790310)Electrophoresis Corp.1979-03-21

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Every clearance here is in the API, with alerts when new ones post.