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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 K053111
Device Name STA-CEPHASCREEN KIT
Applicant
Diagnostica Stago, Inc.
5 Century Dr.
Parisppany,  NJ  07054
Applicant Contact JIM BARROW
Correspondent
Diagnostica Stago, Inc.
5 Century Dr.
Parisppany,  NJ  07054
Correspondent Contact JIM BARROW
Regulation Number864.7925
Classification Product Code
GFO  
Date Received11/04/2005
Decision Date 05/04/2006
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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