FDA applicant
Kamiya Biomedical Co.
FDA records 46 decisions for Kamiya Biomedical Co. (Seattle, WA) from 1991 to 2025: 46 510(k) clearances. Most are in product codes DCK (C-Reactive Protein, Antigen, Antiserum, And…) and DHR (System, Test, Rheumatoid Factor). Its devices cite 5 predicates, 2 of them its own earlier devices. 5 recalls are linked to its devices.
FDA’s records also spell it “Kamiya Biomedical Company”, “Kamiya Biomedical Company, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Kamiya Biomedical Co.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like Kamiya Biomedical Co.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Kamiya”
FDA records each applicant name separately; these may or may not be the same firm.