Cleared Traditional

ELIAS ENA SCREEN (MICROTITER PLATE)

K940622 · Elias U.S.A., Inc. · Immunology
May 1994
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K940622 is an FDA 510(k) clearance for the ELIAS ENA SCREEN (MICROTITER PLATE), a Extractable Antinuclear Antibody, Antigen And Control (Class II — Special Controls, product code LLL), submitted by Elias U.S.A., Inc. (Osceola, US). The FDA issued a Cleared decision on May 11, 1994, 113 days after receiving the submission on January 18, 1994. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K940622 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 1994
Decision Date May 11, 1994
Days to Decision 113 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code LLL — Extractable Antinuclear Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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