Cleared Traditional

VARELISA LA (SS-B) ANTIBODIES

K944168 · Elias U.S.A., Inc. · Immunology
Dec 1994
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K944168 is an FDA 510(k) clearance for the VARELISA LA (SS-B) ANTIBODIES, 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 December 22, 1994, 118 days after receiving the submission on August 26, 1994. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K944168 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 1994
Decision Date December 22, 1994
Days to Decision 118 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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