Cleared Traditional

CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196

K041174 · Sweden Diagnostics (Germany) GmbH · Immunology
Jul 2004
Decision
75d
Days
Class 2
Risk

About This 510(k) Submission

K041174 is an FDA 510(k) clearance for the CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196, a Autoantibodies, Endomysial(tissue Transglutaminase) (Class II — Special Controls, product code MVM), submitted by Sweden Diagnostics (Germany) GmbH (Freiburg, DE). The FDA issued a Cleared decision on July 19, 2004, 75 days after receiving the submission on May 5, 2004. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K041174 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 2004
Decision Date July 19, 2004
Days to Decision 75 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MVM — Autoantibodies, Endomysial(tissue Transglutaminase)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

Similar Devices — MVM Autoantibodies, Endomysial(tissue Transglutaminase)

All 39
Aptiva Celiac Disease IgG Reagent
K200230 · Inova Diagnostics, Inc. · Aug 2021
Aptiva Celiac Disease IgA Reagent
K193604 · Inova Diagnostics, Inc. · Jun 2021
EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay
K181871 · Phadia AB · Mar 2019
EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)
K183313 · Euroimmun Us, Inc. · Feb 2019
IG_PLEX CELIAC DGP PANEL
K140691 · Sqi Diagnostics Systems, Inc. · Nov 2014
IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA
K123713 · Immco Diagnostics, Inc. · Oct 2013