Cleared Traditional

QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS

K113863 · Inova Diagnostics, Inc. · Immunology
Sep 2012
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K113863 is an FDA 510(k) clearance for the QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS, 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 September 20, 2012, 265 days after receiving the submission on December 30, 2011. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K113863 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 2011
Decision Date September 20, 2012
Days to Decision 265 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

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

Similar Devices — MST Antibodies, Gliadin

All 41
ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA
K163177 · Immco Diagnostics, Inc. · Jul 2017
AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK
K132082 · Aesku Diagnostics · Dec 2013
GLIADIN IGA AND GLIADIN LGA
K113377 · Grifols USA, LLC · Dec 2012
QUANTA FLASH (TM) DGP SCREEN
K111414 · Inova Diagnostics, Inc. · Oct 2011
ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01
K093459 · Phadia US, Inc. · Aug 2010
IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA
K091522 · Immco Diagnostics, Inc. · Feb 2010