AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin

Q: What is the product code of K172461?

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) K172461 · Aesku.Diagnostics GmbH & Co. KG

Substantially Equivalent

510(k) numberK172461

Submission

Device name: AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin
Applicant: Aesku.Diagnostics GmbH & Co. KG
Wendelsheim, DE
Received: August 14, 2017
Decision date: March 23, 2018
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
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
K092600	Immulisa PR3 Antibody ElisaMOB · Traditional	Immco Diagnostics, Inc.	10/07/2010SE

More from Immco Diagnostics, Inc.

510(k)	Device	Decision
K172348	AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit…LSW · Traditional	02/16/2018SE
K132082	Aeskulisa Dgp-A, Aeskulisa Dgp-G,Aeskulisa Dgp-CheckMST · Traditional	12/05/2013SE
K120889	Aeskuslides Ana HEP-2DHN · Traditional	10/15/2012SE
K091859	Aesku PR3MOB · Traditional	06/03/2010SE
K091860	Aeskulisa Mpo, Model 30-7303USMOB · Traditional	02/23/2010SE
K081251	Modification to Aeskulisa DS DNA GLSW · Special	05/13/2008SE
K081104	Aeskulisa Ana HEP-2, Ref 30-7115USLKJ · Traditional	05/02/2008SE
K052439	Aeskulisa Glia a and Aeskulisa Glia GMST · Traditional	02/07/2006SE
K041628	Aeskulisa DS DNA GLSW · Traditional	10/14/2004SE
K041753	Aeskulisa Ena 6 SLLL · Traditional	07/14/2004SE

Questions and answers

When was AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin cleared by the FDA?

AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin (K172461) received a 510(k) decision of Substantially Equivalent on March 23, 2018, 221 days after the submission was received.

What is the product code of K172461?

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