FDA.reportPublic FDA data

510(k) K112545

Device
QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM
Applicant
INOVA DIAGNOSTICS, INC.
510(k) number
K112545
Product code
MOB  
Decision
Substantially Equivalent (SESE)
Decision date
2012-07-31
Date received
2011-09-01
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
MICHAEL MAHLER
Address
9900 Old Grove Rd. San Diego CA US 92131 92131

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
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
K070458MODIFICATION TO FIDIS VASCULITIS, MODEL MX007Biomedical Diagnostics (Bmd) SA2007-12-21

Legacy Summary#

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FDA Review#

Decision Summary