Cleared Traditional

EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3

K061376 · Theratest Laboratories, Inc. · Immunology
Jul 2006
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K061376 is an FDA 510(k) clearance for the EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3, a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II — Special Controls, product code MOB), submitted by Theratest Laboratories, Inc. (Lombard, US). The FDA issued a Cleared decision on July 20, 2006, 64 days after receiving the submission on May 17, 2006. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K061376 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 2006
Decision Date July 20, 2006
Days to Decision 64 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

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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