Cleared Traditional

CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996

K041173 · Sweden Diagnostics (Germany) GmbH · Immunology
Aug 2004
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K041173 is an FDA 510(k) clearance for the CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996, a Autoantibodies, Endomysial(tissue Transglutaminase) (Class II — Special Controls, product code MVM), submitted by Sweden Diagnostics (Germany) GmbH (Freiburg, DE). The FDA issued a Cleared decision on August 2, 2004, 89 days after receiving the submission on May 5, 2004. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K041173 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 2004
Decision Date August 02, 2004
Days to Decision 89 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MVM — Autoantibodies, Endomysial(tissue Transglutaminase)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

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