Cleared Traditional

AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA

K002215 · Cogent Diagnotics , Ltd. · Immunology
Sep 2000
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K002215 is an FDA 510(k) clearance for the AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA, a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II — Special Controls, product code MOB), submitted by Cogent Diagnotics , Ltd. (Midlothian Eh26 0pl, GB). The FDA issued a Cleared decision on September 28, 2000, 66 days after receiving the submission on July 24, 2000. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K002215 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 2000
Decision Date September 28, 2000
Days to Decision 66 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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