Cleared Traditional

MDI GLIADIN A TEST

K002358 · Micro Detect, Inc. · Immunology
Oct 2000
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K002358 is an FDA 510(k) clearance for the MDI GLIADIN A TEST, a Antibodies, Gliadin (Class II — Special Controls, product code MST), submitted by Micro Detect, Inc. (Tustin, US). The FDA issued a Cleared decision on October 19, 2000, 78 days after receiving the submission on August 2, 2000. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K002358 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 2000
Decision Date October 19, 2000
Days to Decision 78 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

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

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