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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Prothrombin
510(k) Number K872537
Device Name PROTHROMBIN TIME TEST
Applicant
Sclavo, Inc.
5 Mansard Court
Wayne,  NJ  07470
Applicant Contact DEBRA HOFMEISTER
Correspondent
Sclavo, Inc.
5 Mansard Court
Wayne,  NJ  07470
Correspondent Contact DEBRA HOFMEISTER
Regulation Number864.7750
Classification Product Code
GJS  
Date Received06/25/1987
Decision Date 08/27/1987
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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