Cleared Traditional

VARELISA MPO-ANCA

K953587 · Elias U.S.A., Inc. · Immunology
Jan 1996
Decision
178d
Days
Class 2
Risk

About This 510(k) Submission

K953587 is an FDA 510(k) clearance for the VARELISA MPO-ANCA, a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II — Special Controls, product code MOB), submitted by Elias U.S.A., Inc. (Osceola, US). The FDA issued a Cleared decision on January 26, 1996, 178 days after receiving the submission on August 1, 1995. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K953587 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 1995
Decision Date January 26, 1996
Days to Decision 178 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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