The following data is part of a premarket notification filed by Kamiya Biomedical Company with the FDA for K-assay (r) Rf (ver.2), K-assay (r) Rf Calibrator (ver.2).
| Device ID | K192727 |
| 510k Number | K192727 |
| Device Name: | K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | Kamiya Biomedical Company 12779 Gateway Drive S Tukwila, WA 98168 |
| Contact | Shawn Kaplan |
| Correspondent | Shawn Kaplan Kamiya Biomedical Company 12779 Gateway Drive S Tukwila, WA 98168 |
| Product Code | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-27 |
| Decision Date | 2020-05-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816426021532 | K192727 | 000 |