FDA.reportPublic FDA data

510(k) K041040

Device
VARELISA MPO ANCA, MODEL 17648/17696
Applicant
Sweden Diagnostics (Germany) GmbH
510(k) number
K041040
Product code
MOB
Decision
Substantially Equivalent (SESE)
Decision date
2004-06-16
Date received
2004-04-22
Regulation
866.5660
Classification name
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
MICHAEL LINSS
Address
Munzingerstrasse 7 Freiburg DE D-79111 D-79111

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MOB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243776Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)Zeus Scientific2025-05-07
K172582EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPatternEuroimmun Us, Inc.2018-05-24
K172461AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA FormalinAesku.Diagnostics GmbH & Co. KG2018-03-23
K173792EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM ImmunoassayPhadia AB2018-03-13
K161258NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin KitInova Diagnostics, Inc.2017-02-03
K140225ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM POPhadia US, Inc.2014-10-27
K112545QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBMInova Diagnostics, Inc.2012-07-31
K100917FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEMBiomedical Diagnostics (Bmd) SA2010-11-03
K092600IMMULISA PR3 ANTIBODY ELISAImmco Diagnostics, Inc.2010-10-07
K092599IMMULISA MPO ANTIBODY ELISAImmco Diagnostics, Inc.2010-10-07
K092601IMMULISA ANCA SCREEN ELISAImmco Diagnostics, Inc.2010-10-07
K091859AESKU PR3Aesku Diagnostics2010-06-03
K091860AESKULISA MPO, MODEL 30-7303USAesku Diagnostics2010-02-23
K083850EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMSEuroimmun Us, Inc.2009-05-20
K082130EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG)Euroimmun Us, Inc.2009-04-07