Cleared Traditional

ENCORE ENA COMBINED EIA

K931543 · Clark Laboratories, Inc. · Immunology
Sep 1993
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K931543 is an FDA 510(k) clearance for the ENCORE ENA COMBINED EIA, a Extractable Antinuclear Antibody, Antigen And Control (Class II — Special Controls, product code LLL), submitted by Clark Laboratories, Inc. (Blairstown, US). The FDA issued a Cleared decision on September 8, 1993, 163 days after receiving the submission on March 29, 1993. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K931543 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 1993
Decision Date September 08, 1993
Days to Decision 163 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

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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