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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 K052124
Device Name ACTICLOT, MODEL 824
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 Number864.7750
Classification Product Code
GJS  
Date Received08/05/2005
Decision Date 10/17/2005
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
Recalls CDRH Recalls
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