Source document or public record
FDA 510(k) K242170 — K-ASSAY CRP (Ver.2)
FDA 510(k) index record K242170. Device: K-ASSAY CRP (Ver.2). Applicant as listed: Kamiya Biomedical Company, LLC. Decision date: 2025-04-18.
Source
"device_name": "K-ASSAY CRP (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 K242170.
Device name: K-ASSAY CRP (Ver.2). Applicant as listed: Kamiya Biomedical Company, LLC.
Decision date: 2025-04-18. Decision wording: Substantially Equivalent.
Product code: DCK. Regulation: 21 CFR 866.5270. 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.