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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Coagulation Control
510(k) Number K091284
Device Name VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA
Applicant
Affinity Biologicals, Inc.
1395 Sandhill Dr.
Ancaster, Ontario,  CA L9G 4V5
Applicant Contact DENISE FOULON
Correspondent
Affinity Biologicals, Inc.
1395 Sandhill Dr.
Ancaster, Ontario,  CA L9G 4V5
Correspondent Contact DENISE FOULON
Regulation Number864.5425
Classification Product Code
GGN  
Subsequent Product Code
JIX  
Date Received05/01/2009
Decision Date 10/28/2009
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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