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510(k) K882325

UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST by Sclavo, Inc. — Product Code GFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1988
Date Received
June 6, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activated Partial Thromboplastin
Device Class
Class II
Regulation Number
864.7925
Review Panel
HE
Submission Type

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