K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)
FDA 510(k) clearance K192727 · decided 2020-05-20
Clearance details
- K-number
- K192727
- Device name
- K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)
- Applicant
- Kamiya Biomedical Company
- Decision
- Substantially Equivalent
- Date received
- 2019-09-27
- Decision date
- 2020-05-20
- Days to decision
- 236 days
- Clearance type
- Traditional
- Product code
- DHR
- Device class
- 2
- Regulation number
- 866.5775
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Tukwila, WA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Kamiya Biomedical Company
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API,
or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents (K190088) | Inova Diagnostics, Inc. | 2019-04-17 |
| EliA RF IgM Immunoassay (K182747) | Phadia AB | 2018-12-18 |
| Optilite Rheumatoid Factor Kit (K162263) | The Binding Site Group , Ltd. | 2017-05-03 |
| Rheumatoid Factor (RF) Kit for use on SPAPLUS (K160070) | The Binding Site Group , Ltd. | 2016-12-07 |
| ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA (K143736) | Immco Diagnostics, Inc. | 2015-09-23 |
| RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM (K102673) | Phadia US, Inc. | 2011-09-30 |
| ORGENTEC RHEUMATOID FACTOR EIA (K100499) | Orgentec Diagnostika GmbH | 2010-10-27 |
| IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM (K083080) | Sqi Diagnostics Systems | 2009-10-29 |
| N LATEX RF KIT (K071247) | Dade Behring, Inc. | 2007-08-08 |
| OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105. (K060201) | Olympus America, Inc. | 2006-06-06 |
| MININEPH HUMAN RHEUMATOID FACTOR KIT (K041891) | The Binding Site | 2004-11-05 |
| VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS (K041863) | Ortho-Clinical Diagnostics, Inc. | 2004-09-20 |
Recalls involving this device
No recalls on record reference this clearance.