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510(k) Data Aggregation

K Number

Device Name

GENUA MENOPAUSE MONITOR TEST KIT

Manufacturer

GENUA 1944, INC.

Date Cleared

2001-01-12

(156 days)

Product Code

Regulation Number

Type

Panel

Clinical Chemistry (CH)

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

GENUA 1944, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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