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510(k) K923153

HEMOCARD, HEMOGLOBIN C ASSAY by Isolab, Inc. — Product Code MLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1994
Date Received
June 29, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemoglobin C (Abnormal Hemoglobin Variant)
Device Class
Class II
Regulation Number
864.7415
Review Panel
HE
Submission Type

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