Cleared Traditional

QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls

K163525 · Inova Diagnostics, Inc. · Immunology

Sep 2017

Decision

264d

Days

Class 2

Risk

About This 510(k) Submission

K163525 is an FDA 510(k) clearance for the QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls, a Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DBM), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on September 5, 2017, 264 days after receiving the submission on December 15, 2016. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5090.

Submission Details

510(k) Number	K163525 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 15, 2016
Decision Date	September 05, 2017
Days to Decision	264 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

Product Code	DBM — Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5090