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510(k) Data Aggregation

K Number

Device Name

MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100

Manufacturer

APEX BIOTECHNOLOGY CORP.

Date Cleared

2001-05-18

(25 days)

Product Code

Regulation Number

Type

Panel

Clinical Chemistry

Reference & Predicate Devices

N/A

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Device Name :

MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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