Total clearances
2
2020-05-20 → 2025-04-18
Name variants in FDA filings: Kamiya Biomedical Company / Kamiya Biomedical Company, LLC
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| DCK |
C-Reactive Protein, Antigen, Antiserum, And Control |
Class II |
Immunology |
1 |
2025-04-18 |
| DHR |
System, Test, Rheumatoid Factor |
Class II |
Immunology |
1 |
2020-05-20 |
Safety
Recalls (1)
Class I (serious)
0
Risk of injury / death
| Date | Severity | Status | Recall # |
Product | Code | Reason |
| 2022-09-28 |
Class II
|
Ongoing |
Z-0271-2023 |
K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013 |
— |
IgA Reagent may start showing cloudiness over time, which can affect assay performance. |
Filings
All 510(k) clearances (2)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2025-04-18 |
K242170 |
K-ASSAY CRP (Ver.2) |
DCK |
Class II |
Immunology |
| 2020-05-20 |
K192727 |
K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) |
DHR |
Class II |
Immunology |