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MLL — Hemoglobin C (Abnormal Hemoglobin Variant) Class II

FDA Device Classification

Classification Details

Product Code: MLL
Device Class: Class II
Regulation Number: 864.7415
Submission Type
Review Panel: HE
Medical Specialty: Hematology
Implant: No

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K923153	isolab	HEMOCARD, HEMOGLOBIN C ASSAY	January 27, 1994