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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Heparin
510(k) Number K013637
Device Name ACTICHROME HEPARIN (ANTI-FIIA)
Applicant
American Diagnostica, Inc.
222 Railroad Ave.
Greenwich,  CT  06830
Applicant Contact JOHN BERRYMAN
Correspondent
American Diagnostica, Inc.
222 Railroad Ave.
Greenwich,  CT  06830
Correspondent Contact JOHN BERRYMAN
Regulation Number864.7525
Classification Product Code
KFF  
Date Received11/05/2001
Decision Date 04/16/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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