Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge

K-Number: K201256 · 2022-11-04

ApplicantProcise Diagnostics
Decision Date2022-11-04
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge is a medical device manufactured by Procise Diagnostics. It received FDA 510(k) clearance on 2022-11-04 under approval number K201256. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge?

Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge is a medical device that received FDA 510(k) clearance on 2022-11-04. It is manufactured by Procise Diagnostics. The 510(k) number is K201256.

When was Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge approved by the FDA?

Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge received FDA 510(k) clearance on 2022-11-04, under approval number K201256.

What company makes Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge?

Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge is manufactured by Procise Diagnostics.

What is the FDA product code for Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge?

The FDA product code for Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge is DCK.

Related Devices (Code: DCK)

K142993QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go InstrumentOrion Diagnostica, OY K160712VITROS Chemistry Products hsCRP ReagentOrtho Clinical Diagnostics K192118CRP VarioSENTINEL CH. SpA K191993Yumizen C1200 CRPHORIBA ABX SAS K192028Yumizen C1200 CRPHORIBA ABX SAS K242170K-ASSAY CRP (Ver.2)Kamiya Biomedical Company, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑