Cleared Traditional

AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK

K132082 · Aesku Diagnostics · Immunology
Dec 2013
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K132082 is an FDA 510(k) clearance for the AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK, a Antibodies, Gliadin (Class II — Special Controls, product code MST), submitted by Aesku Diagnostics (Wendelsheim, Rheinland, DE). The FDA issued a Cleared decision on December 5, 2013, 153 days after receiving the submission on July 5, 2013. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K132082 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 2013
Decision Date December 05, 2013
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

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
GLIADIN IGA AND GLIADIN LGA
K113377 · Grifols USA, LLC · Dec 2012
QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS
K113863 · Inova Diagnostics, Inc. · Sep 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