Cleared Traditional

EU-TTG IGA ELISA

K994379 · Scimedx Corp. · Immunology
Feb 2000
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K994379 is an FDA 510(k) clearance for the EU-TTG IGA ELISA, a Autoantibodies, Endomysial(tissue Transglutaminase) (Class II — Special Controls, product code MVM), submitted by Scimedx Corp. (Denvill, US). The FDA issued a Cleared decision on February 18, 2000, 53 days after receiving the submission on December 27, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K994379 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 1999
Decision Date February 18, 2000
Days to Decision 53 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

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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