Cleared Traditional

QUANTA FLASH CENTROMERE

K123880 · Inova Diagnostics, Inc. · Immunology
Feb 2014
Decision
417d
Days
Class 2
Risk

About This 510(k) Submission

K123880 is an FDA 510(k) clearance for the QUANTA FLASH CENTROMERE, a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II — Special Controls, product code LJM), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on February 7, 2014, 417 days after receiving the submission on December 17, 2012. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K123880 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2012
Decision Date February 07, 2014
Days to Decision 417 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code LJM — Antinuclear Antibody (enzyme-labeled), Antigen, Controls
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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