Cleared Traditional

VARELISA ANA-4 SCREEN

K951186 · Elias U.S.A., Inc. · Immunology
Apr 1995
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K951186 is an FDA 510(k) clearance for the VARELISA ANA-4 SCREEN, 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 April 17, 1995, 32 days after receiving the submission on March 16, 1995. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K951186 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 1995
Decision Date April 17, 1995
Days to Decision 32 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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