Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge— 510(k) K201256
Substantially EquivalentProcise Diagnostics
FDA 510(k) clearance K201256 for Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge, Substantially Equivalent on 2022-11-04. Applicant: Procise Diagnostics. Device class: 2.
Clearance details
- Applicant
- Procise Diagnostics
- Product code
- Code DCK
- Device class
- Class 2
- Regulation
- 21 CFR 866.5270
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code DCK
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