DHR — System, Test, Rheumatoid Factor Class II
FDA product code DHR covers "System, Test, Rheumatoid Factor", a Class II medical device regulated under 21 CFR 866.5775. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |