FDA 510(k)

CRP Vario

K-Number: K173833 · 2018-09-27

Decision Date2018-09-27

Product CodeNQD

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

CRP Vario is the device name listed in this FDA 510(k) record. The listed applicant is SENTINEL CH. SpA. It received FDA 510(k) clearance on 2018-09-27 under 510(k) 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. The listed applicant is SENTINEL CH. SpA. The 510(k) number is K173833.

When did CRP Vario receive FDA 510(k) clearance?

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

Who is the listed applicant for CRP Vario?

The FDA 510(k) record lists SENTINEL CH. SpA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRP Vario?

The FDA product code for CRP Vario is NQD.

Other records listing SENTINEL CH. SpA as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242585Cystatin C K211058Lp(a) Ultra K193001Albumin BCP K192118CRP Vario

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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.