Kamiya Biomedical Company, LLC
FDA Regulatory Profile
Kamiya Biomedical Company, LLC appears in FDA public data with 2 recalls, 1 510(k) clearance, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0271-2023, Class II) was initiated on September 28, 2022. Its most recent 510(k) clearance was granted on April 18, 2025.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 1
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0271-2023 | Class II | K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013 | September 28, 2022 |
| Z-3138-2017 | Class II | K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD The | July 19, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K242170 | K-ASSAY CRP (Ver.2) | April 18, 2025 |