UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION

Test, Alpha Fetoprotein L3 Subfraction (afp-l3%), For Hepatocellular Carcinoma Risk Assessment

WAKO CHEMICALS USA, INC.

The following data is part of a premarket notification filed by Wako Chemicals Usa, Inc. with the FDA for Utaswako I30 (includes Accessories), Utaswako Afp-l3, Calibrator Set, Control L, Control H, Sample Dilution.

Pre-market Notification Details

Device IDK100464
510k NumberK100464
Device Name:UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION
ClassificationTest, Alpha Fetoprotein L3 Subfraction (afp-l3%), For Hepatocellular Carcinoma Risk Assessment
Applicant WAKO CHEMICALS USA, INC. 1025 TERRA BELLA AVE SUITE A Mountain View,  CA  94043
ContactMartha Murari
CorrespondentMartha Murari
WAKO CHEMICALS USA, INC. 1025 TERRA BELLA AVE SUITE A Mountain View,  CA  94043
Product CodeNSF  
Subsequent Product CodeJIT
Subsequent Product CodeJJX
Subsequent Product CodeOAU
Subsequent Product CodeOUE
CFR Regulation Number866.6030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-02-18
Decision Date2011-02-23
Summary:summary

NIH GUDID Devices

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