Cleared Traditional

WIELISA PR-3 ANCA TEST SYSTEM

K974167 · Wieslab AB · Immunology
Feb 1998
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K974167 is an FDA 510(k) clearance for the WIELISA PR-3 ANCA TEST SYSTEM, a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II — Special Controls, product code MOB), submitted by Wieslab AB (Frederick, US). The FDA issued a Cleared decision on February 17, 1998, 104 days after receiving the submission on November 5, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K974167 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 1997
Decision Date February 17, 1998
Days to Decision 104 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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