Cleared Traditional

GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM

K002189 · Scimedx Corp. · Immunology
Oct 2000
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K002189 is an FDA 510(k) clearance for the GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM, a Antibodies, Gliadin (Class II — Special Controls, product code MST), submitted by Scimedx Corp. (Denvill, US). The FDA issued a Cleared decision on October 19, 2000, 92 days after receiving the submission on July 19, 2000. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K002189 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 2000
Decision Date October 19, 2000
Days to Decision 92 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code MST — Antibodies, Gliadin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5750

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