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510(k) K875102

DETER. OF HEMOGLOBIN A2 USING THE DIAMAT by Bio-Rad — Product Code JPD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1988
Date Received
December 10, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemoglobin A2 Quantitation
Device Class
Class II
Regulation Number
864.7400
Review Panel
HE
Submission Type

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