Cleared Traditional

WIELISA MPO ANCA TEST SYSTEM

K974166 · Wieslab AB · Immunology
Feb 1998
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K974166 is an FDA 510(k) clearance for the WIELISA MPO 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 K974166 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

Similar Devices — MOB Test System, Antineutrophil Cytoplasmic Antibodies (anca)

All 73
Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)
K243776 · Zeus Scientific · May 2025
EUROIMMUN IFA Granulocyte Mosaic? EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic? EUROPattern
K172582 · Euroimmun Us, Inc. · May 2018
AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin
K172461 · Aesku.Diagnostics GmbH & Co. KG · Mar 2018
EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay
K173792 · Phadia AB · Mar 2018
NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit
K161258 · Inova Diagnostics, Inc. · Feb 2017
ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO
K140225 · Phadia US, Inc. · Oct 2014