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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Qualitative And Quantitative Factor Deficiency
510(k) Number K052825
Device Name VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG
Applicant
AFFINITY BIOLOGICALS INC.
1395 SANDHILL DRIVE
ANCASTER, ONTARIO,  CA L9G 4V5
Applicant Contact DENISE FOULON
Correspondent
AFFINITY BIOLOGICALS INC.
1395 SANDHILL DRIVE
ANCASTER, ONTARIO,  CA L9G 4V5
Correspondent Contact DENISE FOULON
Regulation Number864.7290
Classification Product Code
GGP  
Date Received10/05/2005
Decision Date 01/20/2006
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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