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510(k) K002609

Device
TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
Applicant
ROCHE DIAGNOSTICS CORP.
510(k) number
K002609
Product code
DHR  
Decision
Substantially Equivalent (SESE)
Decision date
2000-09-05
Date received
2000-08-22
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
KAY A TAYLOR
Address
9115 Hague Rd., P.O. Box 50457 Indianapolis IN US 46250 46250

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
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
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

Legacy Summary#

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FDA Review#

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