Cleared Traditional

VARELISA RECOMBI ANA PROFILE, MODEL 18496

K050625 · Sweden Diagnostics (Germany) GmbH · Immunology
Apr 2005
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K050625 is an FDA 510(k) clearance for the VARELISA RECOMBI ANA PROFILE, MODEL 18496, a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II — Special Controls, product code LJM), submitted by Sweden Diagnostics (Germany) GmbH (Freiburg, DE). The FDA issued a Cleared decision on April 26, 2005, 46 days after receiving the submission on March 11, 2005. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K050625 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 2005
Decision Date April 26, 2005
Days to Decision 46 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LJM — Antinuclear Antibody (enzyme-labeled), Antigen, Controls
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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