Cleared Traditional

MARDX ENA EIA TEST SYSTEM

K946218 · Hogan & Hartson · Immunology
May 1995
Decision
145d
Days
Class 2
Risk

About This 510(k) Submission

K946218 is an FDA 510(k) clearance for the MARDX ENA EIA TEST SYSTEM, a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II — Special Controls, product code LJM), submitted by Hogan & Hartson (Washington, US). The FDA issued a Cleared decision on May 15, 1995, 145 days after receiving the submission on December 21, 1994. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K946218 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 1994
Decision Date May 15, 1995
Days to Decision 145 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

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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