Cleared Traditional

VARELISA RECOMBI CTD SCREEN, MODEL 13096

K050967 · Sweden Diagnostics (Germany) GmbH · Immunology
Jun 2005
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K050967 is an FDA 510(k) clearance for the VARELISA RECOMBI CTD SCREEN, MODEL 13096, 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 June 28, 2005, 71 days after receiving the submission on April 18, 2005. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K050967 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 2005
Decision Date June 28, 2005
Days to Decision 71 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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