510(k) K032535
- Device
- MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
- Applicant
- ROCHE DIAGNOSTICS CORP.
- 510(k) number
- K032535
- Product code
- DHR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-09-10
- Date received
- 2003-08-18
- Regulation
- 866.5775
- Classification name
- System, Test, Rheumatoid Factor
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SHERRI L COENEN
- Address
- 9115 Hague Rd., P.O. Box 50457 Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 2084025
- 1421346
- 3005094123
- 3006198300
- 3002800697
- 3005360469
- 8043792
- 3003795116
- 1181121
- 3004973408
- 9680746
- 2050012
- 9610806
- 2245285
- 3005333358
- 2432235
- 9610529
- 3022178699
- 3012963943
- 2250051
- 1641328
- 1832216
- 1319808
- 1649661
- 3002809144
- 3007208259
- 1181055
- 1000403749
- 2020726
- 1318354
- 2250030
- 2026994
- 9610566
- 1827821
- 3011989923
- 2032682
- 3012348571
- 9610746
- 2016706
- 3004493545
- 3016438761
- 3002642396
- 2050010
- 2242436
- 3017505309
- 3015376545
- 3012471076
- 3003871639
- 1616487
- 9610126
- 2029372
- 1319681
- 3021841051
- 3000308930
- 3000148879
- 3010127294
- 9614373
Source Documents#
Other 510(k) Records For Product Code DHR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192727 | K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) | Kamiya Biomedical Company | 2020-05-20 |
| K190088 | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents | Inova Diagnostics, Inc. | 2019-04-17 |
| K182747 | EliA RF IgM Immunoassay | Phadia AB | 2018-12-18 |
| K162263 | Optilite Rheumatoid Factor Kit | The Binding Site Group , Ltd. | 2017-05-03 |
| K160070 | Rheumatoid Factor (RF) Kit for use on SPAPLUS | The Binding Site Group , Ltd. | 2016-12-07 |
| K143736 | ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA | Immco Diagnostics, Inc. | 2015-09-23 |
| K102673 | RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM | Phadia US, Inc. | 2011-09-30 |
| K100499 | ORGENTEC RHEUMATOID FACTOR EIA | Orgentec Diagnostika GmbH | 2010-10-27 |
| K083080 | IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM | Sqi Diagnostics Systems | 2009-10-29 |
| K071247 | N LATEX RF KIT | Dade Behring, Inc. | 2007-08-08 |
| K060201 | OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105. | Olympus America, Inc. | 2006-06-06 |
| K041891 | MININEPH HUMAN RHEUMATOID FACTOR KIT | The Binding Site | 2004-11-05 |
| K041863 | VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS | Ortho-Clinical Diagnostics, Inc. | 2004-09-20 |
| K033802 | ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM | Zeus Scientific, Inc. | 2004-02-27 |
| K024067 | RHEUMATOID FACTOR (RF) | Abbott Laboratories | 2003-01-15 |
Legacy Summary#
summary
FDA Review#
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