Cleared Traditional

QUANTA Flash? LKM-1 Reagents, QUANTA Flash? LKM-1 Calibrators, QUANTA Flash? LKM-1 Controls

K163538 · Inova Diagnostics, Inc. · Immunology

Sep 2017

Decision

264d

Days

Class 2

Risk

About This 510(k) Submission

K163538 is an FDA 510(k) clearance for the QUANTA Flash? LKM-1 Reagents, QUANTA Flash? LKM-1 Calibrators, QUANTA Flash? LKM-1 Controls, a Autoantibodies, Lkm-1 (liver/kidney Microsome, Type 1) (Class II — Special Controls, product code NBS), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on September 6, 2017, 264 days after receiving the submission on December 16, 2016. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number	K163538 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 16, 2016
Decision Date	September 06, 2017
Days to Decision	264 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF