Cleared Traditional

MESACUP TEST PR-3

K040711 · Rhigene, Inc. · Immunology
Apr 2004
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K040711 is an FDA 510(k) clearance for the MESACUP TEST PR-3, a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II — Special Controls, product code MOB), submitted by Rhigene, Inc. (Westminster, US). The FDA issued a Cleared decision on April 2, 2004, 15 days after receiving the submission on March 18, 2004. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K040711 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2004
Decision Date April 02, 2004
Days to Decision 15 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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