Cleared Traditional

THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS

K071692 · Theratest Laboratories, Inc. · Immunology
Nov 2007
Decision
138d
Days
Class 2
Risk

About This 510(k) Submission

K071692 is an FDA 510(k) clearance for the THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS, a Autoantibodies, Endomysial(tissue Transglutaminase) (Class II — Special Controls, product code MVM), submitted by Theratest Laboratories, Inc. (Lombard, US). The FDA issued a Cleared decision on November 5, 2007, 138 days after receiving the submission on June 20, 2007. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K071692 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2007
Decision Date November 05, 2007
Days to Decision 138 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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