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510(k) K100464

Device
UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION
Applicant
WAKO CHEMICALS USA, INC.
510(k) number
K100464
Product code
NSF  
Decision
Substantially Equivalent (SESE)
Decision date
2011-02-23
Date received
2010-02-18
Regulation
866.6030
Classification name
Test, Alpha Fetoprotein L3 Subfraction (afp-l3%), For Hepatocellular Carcinoma Risk Assessment
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MARTHA MURARI
Address
1025 Terra Bella Ave., Suite A Mountain View CA US 94043 94043

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NSF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
DEN050002LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYSWako Chemicals USA, Inc.2005-05-19

Legacy Summary#

summary

FDA Review#

Decision Summary