Cleared Traditional

VARELISA ANA (4) PROFILE

K963291 · Elias U.S.A., Inc. · Immunology
Sep 1996
Decision
40d
Days
Class 2
Risk

About This 510(k) Submission

K963291 is an FDA 510(k) clearance for the VARELISA ANA (4) PROFILE, a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II — Special Controls, product code LJM), submitted by Elias U.S.A., Inc. (Osceola, US). The FDA issued a Cleared decision on September 30, 1996, 40 days after receiving the submission on August 21, 1996. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K963291 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 1996
Decision Date September 30, 1996
Days to Decision 40 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

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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