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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 the device name listed in this FDA 510(k) record. The listed applicant is HORIBA ABX SAS. It received FDA 510(k) clearance on 2021-05-10 under 510(k) 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. The listed applicant is HORIBA ABX SAS. The 510(k) number is K193649.

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

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

Who is the listed applicant for Yumizen C1200 Creatinine PAP?

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 Creatinine PAP?

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

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 H2500K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin MK192028Yumizen C1200 CRPK191562Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid FactorK191993Yumizen C1200 CRPK191245Yumizen C1200 ALP, Yumizen C1200 Albumin

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Related Devices (Code: JFY)

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.

K252619QSCHECK UISACRQstag, Inc.K212223Atellica CH Enzymatic Creatinine_3 (ECre3)Siemens Healthcare Diagnostics, Inc.K182384ACR LAB Urine Analysis Test SystemHealthy.Io, Ltd.K183555GEM Premier ChemSTATInstrumentation Laboratory COK182038URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzerYd Diagnostics CorporationK182063VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated SystemOrtho-Clinical Diagnostics, Inc.

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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