Cleared Traditional

EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay

K181871 · Phadia AB · Immunology
Mar 2019
Decision
232d
Days
Class 2
Risk

About This 510(k) Submission

K181871 is an FDA 510(k) clearance for the EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay, a Autoantibodies, Endomysial(tissue Transglutaminase) (Class II — Special Controls, product code MVM), submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on March 1, 2019, 232 days after receiving the submission on July 12, 2018. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K181871 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 2018
Decision Date March 01, 2019
Days to Decision 232 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

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