Source document or public record
FDA 510(k) K192727 — K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)
FDA 510(k) index record K192727. Device: K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2). Applicant as listed: Kamiya Biomedical Company. Decision date: 2020-05-20.
Source
"device_name": "K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K192727.
Device name: K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2). Applicant as listed: Kamiya Biomedical Company.
Decision date: 2020-05-20. Decision wording: Substantially Equivalent.
Product code: DHR. Regulation: 21 CFR 866.5775. Medical specialty: Immunology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
Interested in these solutions?
Submit a sourcing request with the assays, volumes, and timeline of your own project.