Cleared Traditional

RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11

K992041 · Immuno Concepts, Inc. · Immunology
Jul 1999
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K992041 is an FDA 510(k) clearance for the RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11, a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II — Special Controls, product code LJM), submitted by Immuno Concepts, Inc. (Dallas, US). The FDA issued a Cleared decision on July 23, 1999, 36 days after receiving the submission on June 17, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K992041 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 1999
Decision Date July 23, 1999
Days to Decision 36 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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