Cleared Traditional

RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15

K013285 · Immuno Concepts, Inc. · Immunology
Nov 2001
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K013285 is an FDA 510(k) clearance for the RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15, 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 November 14, 2001, 43 days after receiving the submission on October 2, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K013285 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 2001
Decision Date November 14, 2001
Days to Decision 43 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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