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510(k) Data Aggregation

K Number

Device Name

Manufacturer

MEDTOX DIAGNOSTICS, INC.

Date Cleared

2001-01-17

(169 days)

Product Code

DIS,DJR,JXM,LFG

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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