Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge
FDA 510(k) clearance K201256 · decided 2022-11-04
Clearance details
- K-number
- K201256
- Device name
- Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge
- Applicant
- Procise Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2020-05-11
- Decision date
- 2022-11-04
- Days to decision
- 907 days
- Clearance type
- Traditional
- Product code
- DCK
- Device class
- 2
- Regulation number
- 866.5270
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.