Cleared Traditional

QUANTA FLASH (TM) DGP SCREEN

K111414 · Inova Diagnostics, Inc. · Immunology
Oct 2011
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K111414 is an FDA 510(k) clearance for the QUANTA FLASH (TM) DGP SCREEN, a Antibodies, Gliadin (Class II — Special Controls, product code MST), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on October 20, 2011, 153 days after receiving the submission on May 20, 2011. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K111414 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 2011
Decision Date October 20, 2011
Days to Decision 153 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code MST — Antibodies, Gliadin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5750

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