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510(k) Data Aggregation

K Number

Device Name

ConcizuTrace ELISA

Manufacturer

Randox Laboratories Ltd

Date Cleared

2025-05-22

(325 days)

Product Code

Regulation Number

Type

Panel

Hepatology / Hepatic (HE)

Reference & Predicate Devices

N/A

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Device Name :

ConcizuTrace ELISA

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

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AI/ML Overview

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