Cleared Traditional

DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM

K012797 · Diamedix Corp. · Immunology
Sep 2001
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K012797 is an FDA 510(k) clearance for the DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM, a Antibodies, Gliadin (Class II — Special Controls, product code MST), submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on September 28, 2001, 38 days after receiving the submission on August 21, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K012797 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2001
Decision Date September 28, 2001
Days to Decision 38 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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