Wielisa Anti-Gbm, Anca Screening Kit Test System

Q: What is the product code of K981750?

The FDA product code is MOB – Test System, Antineutrophil Cytoplasmic Antibodies (Anca), a Class II (moderate risk) device regulated under 21 CFR 866.5660.

FDA 510(k) K981750 · Wieslab AB

Substantially Equivalent

510(k) numberK981750

Submission

Device name: Wielisa Anti-Gbm, Anca Screening Kit Test System
Applicant: Wieslab AB
Frederick, MD, US
Received: May 18, 1998
Decision date: July 22, 1998
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: MOB – Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.5660
Specialty: Immunology

Other 510(k)s with product code MOB

510(k)	Device	Applicant	Decision
K261466	Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBMMOB · Traditional	Zeus Scientific	08/21/2026SE
K243776	Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic…MOB · Traditional	Zeus Scientific	05/07/2025SE
K172582	EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic…MOB · Traditional	Euroimmun Us, Inc.	05/24/2018SE
K172461	AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA FormalinMOB · Traditional	Aesku.Diagnostics GmbH & Co. KG	03/23/2018SE
K173792	EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM ImmunoassayMOB · Traditional	Phadia AB	03/13/2018SE
K161258	NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin KitMOB · Traditional	Inova Diagnostics, Inc.	02/03/2017SE
K140225	Elia PR3S Immunoassay, Elia Mpos Immunoassay, Elia GBM Immunoassay, Elia Anca/Gbm…MOB · Traditional	Phadia US, Inc.	10/27/2014SE
K112545	Quanta Flash PR3, Quanta Flash Mpo, Quanta Flash GBMMOB · Traditional	Inova Diagnostics, Inc.	07/31/2012SE
K100917	Fidis Vasculitis Assay Kit and Analyzer and Caris SystemMOB · Special	Biomedical Diagnostics (Bmd) SA	11/03/2010SE
K092601	Immulisa Anca Screen ElisaMOB · Traditional	Immco Diagnostics, Inc.	10/07/2010SE

More from Immco Diagnostics, Inc.

510(k)	Device	Decision
K981748	Wielisa Anca Screening Kit Test SystemMOB · Traditional	07/22/1998SE
K974169	Wielisa Anti-Gbm Test SystemDBL · Traditional	02/17/1998SE
K974167	Wielisa PR-3 Anca Test SystemMOB · Traditional	02/17/1998SE
K974166	Wielisa Mpo Anca Test SystemMOB · Traditional	02/17/1998SE

Questions and answers

When was Wielisa Anti-Gbm, Anca Screening Kit Test System cleared by the FDA?

Wielisa Anti-Gbm, Anca Screening Kit Test System (K981750) received a 510(k) decision of Substantially Equivalent on July 22, 1998, 65 days after the submission was received.

What is the product code of K981750?

The FDA product code is MOB – Test System, Antineutrophil Cytoplasmic Antibodies (Anca), a Class II (moderate risk) device regulated under 21 CFR 866.5660.