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510(k) Data Aggregation

K Number

Device Name

Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)

Manufacturer

Date Cleared

2024-07-26

(102 days)

Product Code

Regulation Number

Type

Panel

Gastroenterology-Urology (GU)

Reference & Predicate Devices

N/A

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Device Name :

Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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