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510(k) K000535

Device
QUANTA LITE LKM-1 ELISA
Applicant
INOVA DIAGNOSTICS, INC.
510(k) number
K000535
Product code
NBS  
Decision
Substantially Equivalent (SESE)
Decision date
2000-06-07
Date received
2000-02-17
Regulation
866.5660
Classification name
Autoantibodies, Lkm-1 (liver/kidney Microsome, Type 1)
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
GARY L NORMAN
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 NBS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K163538QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 ControlsInova Diagnostics, Inc.2017-09-06
K112223EUROIMMUN ANTI-LKM-1 ELISA(LGG)Euroimmun US2012-09-11

Legacy Summary#

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FDA Review#

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