K192727 is an FDA 510(k) clearance for the K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2). This device is classified as a System, Test, Rheumatoid Factor (Class II - Special Controls, product code DHR).
Submitted by Kamiya Biomedical Company (Tukwila, US). The FDA issued a Cleared decision on May 20, 2020, 236 days after receiving the submission on September 27, 2019.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5775.
| 510(k) Number | K192727 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2019 |
| Decision Date | May 20, 2020 |
| Days to Decision | 236 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DHR - System, Test, Rheumatoid Factor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5775 |