Cleared Traditional

QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM

K112545 · Inova Diagnostics, Inc. · Immunology
Jul 2012
Decision
334d
Days
Class 2
Risk

About This 510(k) Submission

K112545 is an FDA 510(k) clearance for the QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM, a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II — Special Controls, product code MOB), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on July 31, 2012, 334 days after receiving the submission on September 1, 2011. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K112545 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 2011
Decision Date July 31, 2012
Days to Decision 334 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code MOB — Test System, Antineutrophil Cytoplasmic Antibodies (anca)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

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