Kamiya Biomedical Company, LLC
Kamiya Biomedical Company, LLC holds FDA 510(k) medical device clearance, cleared in 2025, with 2 FDA device recalls on record.
Top product codes for Kamiya Biomedical Company, LLC
FDA recalls by Kamiya Biomedical Company, LLC
- Z-0271-2023 — K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
- Z-3138-2017 — K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD The K-ASSAY(R) Multi-Analyte Calibrator is intended to be used for the calibration of the K-ASSAY(R) Alpha-1 Acid Glycoprotein, Alpha-1 Anti-Trypsin, Complement C3, Complement C4, Haptoglobin, lgA, lgG, lgM, and Transferrin immunoturbidimetric assays. For in vitro diagnostic use
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Kamiya Biomedical Company, LLC
Data sourced from openFDA. This site is unofficial and independent of the FDA.