Cleared Traditional

VARELISA GLIADIN IGG ANTIBODIES

K041357 · Sweden Diagnostics (Germany) GmbH · Immunology
Aug 2004
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K041357 is an FDA 510(k) clearance for the VARELISA GLIADIN IGG ANTIBODIES, 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 August 2, 2004, 74 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 K041357 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 2004
Decision Date August 02, 2004
Days to Decision 74 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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