510(k) K112223

Device: EUROIMMUN ANTI-LKM-1 ELISA(LGG)
Applicant: EUROIMMUN US
510(k) number: K112223
Product code: NBS
Decision: Substantially Equivalent (SESE)
Decision date: 2012-09-11
Date received: 2011-08-02
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: Summary
Third party reviewed: No

Applicant Contact#

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

FDA Registration Numbers#

2026994
3003268355
3007361513
3012348571
3007118747

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NBS #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K163538	QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls	Inova Diagnostics, Inc.	2017-09-06
K000535	QUANTA LITE LKM-1 ELISA	Inova Diagnostics, Inc.	2000-06-07

Legacy Summary#

summary

FDA Review#

Decision Summary