LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS

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

WAKO CHEMICALS, USA, INC.

The following data is part of a De Novo classification by Wako Chemicals, Usa, Inc. with the FDA for Lba Afp-l3, Afp-l3 Calibrator Set, Afp-l3 Control Set And Libasys.

Pre-market Notification Details

DeNovo IDDEN050002
Device Name:LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS
ClassificationTest, Alpha Fetoprotein L3 Subfraction (afp-l3%), For Hepatocellular Carcinoma Risk Assessment
Applicant WAKO CHEMICALS, USA, INC. 1600 Bellwood Road Richmond,  VA  23237
ContactTonya Mallory
Product CodeNSF  
CFR Regulation Number866.6030 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationK041847
Review Advisory BoardImmunology
Classification AdvisoryImmunology
TypePost-NSE
Date Received2005-04-07
Decision Date2005-05-19
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

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