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FDA 510(k)

CRP Vario

K-Number: K192118 · 2019-11-08

ApplicantSENTINEL CH. SpA
Decision Date2019-11-08
Product CodeDCK
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 2019-11-08 under 510(k) 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. The listed applicant is SENTINEL CH. SpA. The 510(k) number is K192118.

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

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

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 DCK.

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 CK211058Lp(a) UltraK193001Albumin BCPK173833CRP Vario

Related Devices (Code: DCK)

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.

K242170K-ASSAY CRP (Ver.2)Kamiya Biomedical Company, LLCK201256Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeProcise DiagnosticsK192028Yumizen C1200 CRPHORIBA ABX SASK191993Yumizen C1200 CRPHORIBA ABX SASK160712VITROS Chemistry Products hsCRP ReagentOrtho Clinical DiagnosticsK142993QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go InstrumentOrion Diagnostica, OY

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.

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