Source document or public record
FDA 510(k) K201256 — Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge
FDA 510(k) index record K201256. Device: Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge. Applicant as listed: Procise Diagnostics. Decision date: 2022-11-04.
Source
"device_name": "Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K201256.
Device name: Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge. Applicant as listed: Procise Diagnostics.
Decision date: 2022-11-04. Decision wording: Substantially Equivalent.
Product code: DCK. Regulation: 21 CFR 866.5270. Medical specialty: Immunology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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