510(k) K163538

Device: QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls
Applicant: INOVA DIAGNOSTICS, INC.
510(k) number: K163538
Product code: NBS
Decision: Substantially Equivalent (SESE)
Decision date: 2017-09-06
Date received: 2016-12-16
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#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
08426950767008	QUANTA Flash® LKM-1 Reagents	INOVA DIAGNOSTICS, INC.	2017-12-15
08426950766995	QUANTA Flash® LKM-1 Controls	INOVA DIAGNOSTICS, INC.	2017-12-15
08426950766988	QUANTA Flash® Lkm-1 Calibrators	INOVA DIAGNOSTICS, INC.	2017-12-15

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K112223	EUROIMMUN ANTI-LKM-1 ELISA(LGG)	Euroimmun US	2012-09-11
K000535	QUANTA LITE LKM-1 ELISA	Inova Diagnostics, Inc.	2000-06-07

summary

Decision Summary