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510(k) Data Aggregation

K Number

Device Name

DRX HBA1C - FOR PRESCRIPTION HOME USE

Manufacturer

Date Cleared

2000-09-26

(190 days)

Product Code

Regulation Number

Type

Panel

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N/A

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Device Name :

DRX HBA1C - FOR PRESCRIPTION HOME USE

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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