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510(k) K113439

Device
EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG)
Applicant
EUROIMMUN US
510(k) number
K113439
Product code
NIY  
Decision
Substantially Equivalent (SESE)
Decision date
2013-04-12
Date received
2011-11-21
Regulation
866.5660
Classification name
Autoantibodies, Anti-soluble Liver Antigen (sla), Autoimmune Hepatitis
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KATHRYN KOHL
Address
1100 The American Rd. Morris Plains NJ US 07950 07950

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NIY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K112221EUROIMMUN ANTI-SLA/LP ELISA(LGG)Euroimmun US2012-09-11
K021482QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISAInova Diagnostics, Inc.2002-07-30

Legacy Summary#

summary

FDA Review#

Decision Summary