FDA.reportPublic FDA data

510(k) K190088

Device
QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents
Applicant
Inova Diagnostics, Inc.
510(k) number
K190088
Product code
DHR  
Decision
Substantially Equivalent (SESE)
Decision date
2019-04-17
Date received
2019-01-17
Regulation
866.5775
Classification name
System, Test, Rheumatoid Factor
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Roger Albesa
Address
9900 Old Grove Rd. San Diego CA US 92131 92131

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DHR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K192727K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)Kamiya Biomedical Company2020-05-20
K182747EliA RF IgM ImmunoassayPhadia AB2018-12-18
K162263Optilite Rheumatoid Factor KitThe Binding Site Group , Ltd.2017-05-03
K160070Rheumatoid Factor (RF) Kit for use on SPAPLUSThe Binding Site Group , Ltd.2016-12-07
K143736ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISAImmco Diagnostics, Inc.2015-09-23
K102673RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEMPhadia US, Inc.2011-09-30
K100499ORGENTEC RHEUMATOID FACTOR EIAOrgentec Diagnostika GmbH2010-10-27
K083080IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORMSqi Diagnostics Systems2009-10-29
K071247N LATEX RF KITDade Behring, Inc.2007-08-08
K060201OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105.Olympus America, Inc.2006-06-06
K041891MININEPH HUMAN RHEUMATOID FACTOR KITThe Binding Site2004-11-05
K041863VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FSOrtho-Clinical Diagnostics, Inc.2004-09-20
K033802ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEMZeus Scientific, Inc.2004-02-27
K032535MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEMRoche Diagnostics Corp.2003-09-10
K024067RHEUMATOID FACTOR (RF)Abbott Laboratories2003-01-15