FDA 510(k)

CRP Vario

K-Number: K192118 · 2019-11-08

Decision Date2019-11-08

Product CodeDCK

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

CRP Vario is a medical device manufactured by SENTINEL CH. SpA. It received FDA 510(k) clearance on 2019-11-08 under approval number K192118. 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 CRP Vario?

CRP Vario is a medical device that received FDA 510(k) clearance on 2019-11-08. It is manufactured by SENTINEL CH. SpA. The 510(k) number is K192118.

When was CRP Vario approved by the FDA?

CRP Vario received FDA 510(k) clearance on 2019-11-08, under approval number K192118.

What company makes CRP Vario?

CRP Vario is manufactured by SENTINEL CH. SpA.

What is the FDA product code for CRP Vario?

The FDA product code for CRP Vario is DCK.

Other Devices by SENTINEL CH. SpA

K173833CRP Vario K193001Albumin BCP K211058Lp(a) Ultra K242585Cystatin C

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 K191993Yumizen C1200 CRPHORIBA ABX SAS K192028Yumizen C1200 CRPHORIBA ABX SAS K201256Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeProcise Diagnostics K242170K-ASSAY CRP (Ver.2)Kamiya Biomedical Company, LLC

Official Source

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