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510(k) K954048

VARIANT HEMOGLOBINOPATHY PROGRAM by Bio-Rad — Product Code GKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1995
Date Received
August 28, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Abnormal Hemoglobin Quantitation
Device Class
Class II
Regulation Number
864.7415
Review Panel
HE
Submission Type

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