Cleared Traditional

VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896

K041354 · Sweden Diagnostics (Germany) GmbH · Immunology
Jul 2004
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K041354 is an FDA 510(k) clearance for the VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896, a Antibodies, Gliadin (Class II — Special Controls, product code MST), submitted by Sweden Diagnostics (Germany) GmbH (Freiburg, DE). The FDA issued a Cleared decision on July 16, 2004, 57 days after receiving the submission on May 20, 2004. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K041354 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 2004
Decision Date July 16, 2004
Days to Decision 57 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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