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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activated Partial Thromboplastin
510(k) Number K882325
Device Name UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
Applicant
Sclavo, Inc.
5 Mansard Ct.
Wayne,  NJ  07470
Correspondent
Sclavo, Inc.
5 Mansard Ct.
Wayne,  NJ  07470
Regulation Number864.7925
Classification Product Code
GFO  
Date Received06/06/1988
Decision Date 08/25/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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