Control, Hemoglobin
FDA product code GGM · 15 cleared devices
Class 2
Hematology
- Regulation
- 21 CFR 864.8625
- Review panel
- HE
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1979-03-21 – 2019-11-15
GGM
2019-11-15
GGM
2019-02-01
HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High
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GGM
2007-04-02
LYPHOCHEK DIABETES CONTROL
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GGM
2007-03-29
R&D SICKLE QC CONTROL
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GGM
2005-11-09
LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4
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GGM
2003-10-30
GLYCOHEMOSURE HBA1C CONTROL
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GGM
2000-11-29
LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET
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GGM
1999-11-12
R&D HGB/GLC WHOLE BLOOD CONTROL
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GGM
1996-11-06
HEMOCUE HEMOTROL
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GGM
1996-10-16
HEMOCUE HEMOLIN
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GGM
1992-11-17
CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL
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GGM
1989-08-15
HGB-CONTROL SET/MULTIPLE
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GGM
1985-07-05
PRECINORM HB
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GGM
1980-03-05
WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3
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GGM
1979-03-21
HEMOGLOBIN CONTROLS
View details →No matching devices.
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