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FDA 510(k)

CRP Vario

K-Number: K173833 · 2018-09-27

ApplicantSENTINEL CH. SpA
Decision Date2018-09-27
Product CodeNQD
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CRP Vario is a medical device manufactured by SENTINEL CH. SpA. It received FDA 510(k) clearance on 2018-09-27 under approval number K173833. The device is classified under product code NQD. 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 2018-09-27. It is manufactured by SENTINEL CH. SpA. The 510(k) number is K173833.

When was CRP Vario approved by the FDA?

CRP Vario received FDA 510(k) clearance on 2018-09-27, under approval number K173833.

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 NQD.

Other Devices by SENTINEL CH. SpA

K193001Albumin BCP K192118CRP Vario K211058Lp(a) Ultra K242585Cystatin C

Related Devices (Code: NQD)

K212559CardioPhase® hsCRPSiemens Healthcare Diagnostics Products GmbH K233242Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)Siemens Healthcare Diagnostics, Inc. K260026Tina-quant Cardiac high sensitivity CRP IIIRoche Diagnostics

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.

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