FDA 510(k)

Yumizen C1200 CRP

K-Number: K192028 · 2020-06-25

Decision Date2020-06-25

Product CodeDCK

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

Yumizen C1200 CRP is the device name listed in this FDA 510(k) record. The listed applicant is HORIBA ABX SAS. It received FDA 510(k) clearance on 2020-06-25 under 510(k) number K192028. 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 Yumizen C1200 CRP?

Yumizen C1200 CRP is a medical device that received FDA 510(k) clearance on 2020-06-25. The listed applicant is HORIBA ABX SAS. The 510(k) number is K192028.

When did Yumizen C1200 CRP receive FDA 510(k) clearance?

Yumizen C1200 CRP received FDA 510(k) clearance on 2020-06-25, under 510(k) number K192028.

Who is the listed applicant for Yumizen C1200 CRP?

The FDA 510(k) record lists HORIBA ABX SAS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Yumizen C1200 CRP?

The FDA product code for Yumizen C1200 CRP is DCK.

Other records listing HORIBA ABX SAS 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.

K232946Yumizen H2500 K193649Yumizen C1200 Creatinine PAP K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M K191562Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor K191993Yumizen C1200 CRP K191245Yumizen C1200 ALP, Yumizen C1200 Albumin

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Related Devices (Code: DCK)

K242170K-ASSAY CRP (Ver.2)Kamiya Biomedical Company, LLC K201256Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeProcise Diagnostics K192118CRP VarioSENTINEL CH. SpA K191993Yumizen C1200 CRPHORIBA ABX SAS K160712VITROS Chemistry Products hsCRP ReagentOrtho Clinical Diagnostics K142993QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go InstrumentOrion Diagnostica, OY

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.