DHR — System, Test, Rheumatoid Factor Class II
FDA Device Classification
Classification Details
- Product Code
- DHR
- Device Class
- Class II
- Regulation Number
- 866.5775
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K192727 | kamiya biomedical | K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) | May 20, 2020 |
| K190088 | inova diagnostics | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents | April 17, 2019 |
| K182747 | phadia | EliA RF IgM Immunoassay | December 18, 2018 |
| K162263 | binding site group | Optilite Rheumatoid Factor Kit | May 3, 2017 |
| K160070 | binding site group | Rheumatoid Factor (RF) Kit for use on SPAPLUS | December 7, 2016 |
| K143736 | immco diagnostics | ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA | September 23, 2015 |
| K102673 | phadia us | RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM | September 30, 2011 |
| K100499 | orgentec diagnostika | ORGENTEC RHEUMATOID FACTOR EIA | October 27, 2010 |
| K083080 | sqi diagnostics systems | IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM | October 29, 2009 |
| K071247 | dade behring | N LATEX RF KIT | August 8, 2007 |
| K060201 | olympus america | OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028 | June 6, 2006 |
| K041891 | binding site | MININEPH HUMAN RHEUMATOID FACTOR KIT | November 5, 2004 |
| K041863 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 | September 20, 2004 |
| K033802 | zeus scientific | ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM | February 27, 2004 |
| K032535 | roche diagnostics | MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM | September 10, 2003 |
| K024067 | abbott laboratories | RHEUMATOID FACTOR (RF) | January 15, 2003 |
| K020972 | wako chemicals usa | WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET | September 9, 2002 |
| K021394 | diamedix | DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM | July 9, 2002 |
| K002609 | roche diagnostics | TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM | September 5, 2000 |
| K000534 | roche diagnostics | COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II | April 5, 2000 |