Cleared Traditional

IMMUNO CONCEPTS ANCA TEST SYSTEM

K974463 · Immuno Concepts, Inc. · Immunology
Feb 1998
Decision
75d
Days
Class 2
Risk

About This 510(k) Submission

K974463 is an FDA 510(k) clearance for the IMMUNO CONCEPTS ANCA TEST SYSTEM, a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II — Special Controls, product code MOB), submitted by Immuno Concepts, Inc. (Dallas, US). The FDA issued a Cleared decision on February 9, 1998, 75 days after receiving the submission on November 26, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K974463 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 1997
Decision Date February 09, 1998
Days to Decision 75 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MOB — Test System, Antineutrophil Cytoplasmic Antibodies (anca)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

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