Cleared Traditional

WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM

K981750 · Wieslab AB · Immunology
Jul 1998
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K981750 is an FDA 510(k) clearance for the WIELISA ANTI-GBM, ANCA SCREENING KIT 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 July 22, 1998, 65 days after receiving the submission on May 18, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K981750 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 1998
Decision Date July 22, 1998
Days to Decision 65 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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