Cleared Traditional

VARELISA COMBINED DNA ANTIBODIES EIA

K944334 · Elias U.S.A., Inc. · Immunology
Apr 1995
Decision
223d
Days
Class 2
Risk

About This 510(k) Submission

K944334 is an FDA 510(k) clearance for the VARELISA COMBINED DNA ANTIBODIES EIA, a Anti-dna Antibody (enzyme-labeled), Antigen, Control (Class II — Special Controls, product code LRM), submitted by Elias U.S.A., Inc. (Osceola, US). The FDA issued a Cleared decision on April 17, 1995, 223 days after receiving the submission on September 6, 1994. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K944334 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 1994
Decision Date April 17, 1995
Days to Decision 223 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code LRM — Anti-dna Antibody (enzyme-labeled), Antigen, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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