FDA.reportPublic FDA data

510(k) K143736

Device
ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA
Applicant
IMMCO DIAGNOSTICS, INC.
510(k) number
K143736
Product code
DHR  
Decision
Substantially Equivalent (SESE)
Decision date
2015-09-23
Date received
2014-12-30
Regulation
866.5775
Classification name
System, Test, Rheumatoid Factor
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Kevin Lawson
Address
9870 Hollingson Rd. Clarence NY US 14031 14031

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K190088QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsInova Diagnostics, Inc.2019-04-17
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
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

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Decision Summary