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FDA 510(k)

Yumizen C1200 Creatinine PAP

K-Number: K193649 · 2021-05-10

ApplicantHORIBA ABX SAS
Decision Date2021-05-10
Product CodeJFY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Yumizen C1200 Creatinine PAP is a medical device manufactured by HORIBA ABX SAS. It received FDA 510(k) clearance on 2021-05-10 under approval number K193649. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Yumizen C1200 Creatinine PAP?

Yumizen C1200 Creatinine PAP is a medical device that received FDA 510(k) clearance on 2021-05-10. It is manufactured by HORIBA ABX SAS. The 510(k) number is K193649.

When was Yumizen C1200 Creatinine PAP approved by the FDA?

Yumizen C1200 Creatinine PAP received FDA 510(k) clearance on 2021-05-10, under approval number K193649.

What company makes Yumizen C1200 Creatinine PAP?

Yumizen C1200 Creatinine PAP is manufactured by HORIBA ABX SAS.

What is the FDA product code for Yumizen C1200 Creatinine PAP?

The FDA product code for Yumizen C1200 Creatinine PAP is JFY.

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 K192028Yumizen C1200 CRP

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Related Devices (Code: JFY)

K152835URITEK TC-201 URINE CHEMISTRY TEST SYSTEMTeco Diagnostics, Inc. K161527Teco Creatinine Enzymatic Reagent KitTeco Diagnostics, Inc. K182038URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzerYd Diagnostics Corporation K182063VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated SystemOrtho-Clinical Diagnostics, Inc. K182384ACR LAB Urine Analysis Test SystemHealthy.Io, Ltd. K183555GEM Premier ChemSTATInstrumentation Laboratory CO

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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