Cleared Traditional

VARELISA SM ANTIBODIES, MODEL 18296

K042629 · Sweden Diagnostics (Germany) GmbH · Immunology
Dec 2004
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K042629 is an FDA 510(k) clearance for the VARELISA SM ANTIBODIES, MODEL 18296, a Anti-sm Antibody, Antigen And Control (Class II — Special Controls, product code LKP), submitted by Sweden Diagnostics (Germany) GmbH (Freiburg, DE). The FDA issued a Cleared decision on December 8, 2004, 72 days after receiving the submission on September 27, 2004. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K042629 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2004
Decision Date December 08, 2004
Days to Decision 72 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LKP — Anti-sm Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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