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510(k) K021482

Device
QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA
Applicant
INOVA DIAGNOSTICS, INC.
510(k) number
K021482
Product code
NIY  
Decision
Substantially Equivalent (SESE)
Decision date
2002-07-30
Date received
2002-05-08
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
BRYS C MYERS
Address
10180 Scripps Ranch Blvd. San Diego CA US 92131 92131

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NIY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K113439EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG)Euroimmun US2013-04-12
K112221EUROIMMUN ANTI-SLA/LP ELISA(LGG)Euroimmun US2012-09-11

Legacy Summary#

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FDA Review#

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