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Abnormal Hemoglobin Quantitation

FDA product code GKA · 23 cleared devices

Class 2 Hematology
Regulation
21 CFR 864.7415
Review panel
HE
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
1981-07-27 – 2024-04-04
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