Cleared Traditional

MESACUP TEST MPO, MODEL 11053

K040586 · Rhigene, Inc. · Immunology
Mar 2004
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K040586 is an FDA 510(k) clearance for the MESACUP TEST MPO, MODEL 11053, 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 March 22, 2004, 17 days after receiving the submission on March 5, 2004. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K040586 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2004
Decision Date March 22, 2004
Days to Decision 17 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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