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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
510(k) Number K080069
Device Name DIMERTEST
Applicant
American Diagnostica, Inc.
500 W. Ave.
Stamford,  CT  06902
Applicant Contact LEIGH AYRES
Correspondent
American Diagnostica, Inc.
500 W. Ave.
Stamford,  CT  06902
Correspondent Contact LEIGH AYRES
Regulation Number864.7320
Classification Product Code
DAP  
Date Received01/10/2008
Decision Date 02/13/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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