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510(k) Data Aggregation

K Number

Device Name

HEMOCUE B-HEMOGLOBIN SYSTEM

Manufacturer

Date Cleared

1996-09-24

(173 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

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Device Name :

HEMOCUE B-HEMOGLOBIN SYSTEM

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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