Cleared Traditional

Aptiva Celiac Disease IgA Reagent

K193604 · Inova Diagnostics, Inc. · Immunology
Jun 2021
Decision
541d
Days
Class 2
Risk

About This 510(k) Submission

K193604 is an FDA 510(k) clearance for the Aptiva Celiac Disease IgA Reagent, a Autoantibodies, Endomysial(tissue Transglutaminase) (Class II — Special Controls, product code MVM), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on June 16, 2021, 541 days after receiving the submission on December 23, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K193604 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2019
Decision Date June 16, 2021
Days to Decision 541 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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