K-ASSAY CRP (Ver.2)
FDA 510(k) clearance K242170 · decided 2025-04-18
Clearance details
- K-number
- K242170
- Device name
- K-ASSAY CRP (Ver.2)
- Applicant
- Kamiya Biomedical Company, LLC
- Decision
- Substantially Equivalent
- Date received
- 2024-07-24
- Decision date
- 2025-04-18
- Days to decision
- 268 days
- Clearance type
- Traditional
- Product code
- DCK
- Device class
- 2
- Regulation number
- 866.5270
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Tukwila, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.