Product code GGM— Hematology
CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL
- Classification name
- Control, Hemoglobin
- Device class
- Class 2
- Regulation
- 21 CFR 864.8625
- Advisory panel
- Hematology
- Total cleared
- 15
- First cleared
- Most recent
Market context for product code GGM
FDA has cleared devices under product code GGM between 1979 and 2019, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2019
- 2007
- 2005
- 2003
- 2000
- 1999
- 1996
- 1992
- 1989
- 1985
- 1980
- 1979
Top applicants under product code GGM
Recent clearances under product code GGM
- K192842 — HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High
- K182744 — HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High
- K070546 — LYPHOCHEK DIABETES CONTROL
- K070334 — R&D SICKLE QC CONTROL
- K052838 — LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4
- K032791 — GLYCOHEMOSURE HBA1C CONTROL
- K003030 — LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET
- K993321 — R&D HGB/GLC WHOLE BLOOD CONTROL
- K964052 — HEMOCUE HEMOTROL
- K963908 — HEMOCUE HEMOLIN
- K921681 — CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL
- K893985 — HGB-CONTROL SET/MULTIPLE
- K852136 — PRECINORM HB
- K800296 — WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3
- K790310 — HEMOGLOBIN CONTROLS
Data sourced from openFDA. This site is unofficial and independent of the FDA.