Cleared Traditional

EUROSPITAL EU-TTG IGA UMANA

K010625 · Scimedx Corp. · Immunology
Apr 2001
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K010625 is an FDA 510(k) clearance for the EUROSPITAL EU-TTG IGA UMANA, a Autoantibodies, Endomysial(tissue Transglutaminase) (Class II — Special Controls, product code MVM), submitted by Scimedx Corp. (Denville, US). The FDA issued a Cleared decision on April 24, 2001, 53 days after receiving the submission on March 2, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K010625 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2001
Decision Date April 24, 2001
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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