Yumizen C1200 CRP
K-Number: K192028 · 2020-06-25
ApplicantHORIBA ABX SAS
Decision Date2020-06-25
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
Yumizen C1200 CRP is a medical device manufactured by HORIBA ABX SAS. It received FDA 510(k) clearance on 2020-06-25 under approval 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. It is manufactured by HORIBA ABX SAS. The 510(k) number is K192028.
When was Yumizen C1200 CRP approved by the FDA?
Yumizen C1200 CRP received FDA 510(k) clearance on 2020-06-25, under approval number K192028.
What company makes Yumizen C1200 CRP?
Yumizen C1200 CRP is manufactured by HORIBA ABX SAS.
What is the FDA product code for Yumizen C1200 CRP?
The FDA product code for Yumizen C1200 CRP is DCK.
Other Devices by HORIBA ABX SAS
K170353ABX MICROS ES 60 OT and ABX MICROS ES 60 CT
K191993Yumizen C1200 CRP
K191245Yumizen C1200 ALP, Yumizen C1200 Albumin
K191396Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe
K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M
K191562Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor
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
K192118CRP VarioSENTINEL CH. SpA
K191993Yumizen C1200 CRPHORIBA ABX SAS
K201256Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeProcise Diagnostics
K242170K-ASSAY CRP (Ver.2)Kamiya Biomedical Company, LLC
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.