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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment
510(k) Number K100464
Device Name UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION
Applicant
WAKO CHEMICALS USA, INC.
1025 TERRA BELLA AVE
SUITE A
MOUNTAIN VIEW,  CA  94043
Applicant Contact MARTHA MURARI
Correspondent
WAKO CHEMICALS USA, INC.
1025 TERRA BELLA AVE
SUITE A
MOUNTAIN VIEW,  CA  94043
Correspondent Contact MARTHA MURARI
Regulation Number866.6030
Classification Product Code
NSF  
Subsequent Product Codes
JIT   JJX   OAU   OUE  
Date Received02/18/2010
Decision Date 02/23/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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