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510(k) Data Aggregation

K Number

Device Name

MODIFICATION TO RAPID DRUG SCREEN 9-PANEL

Manufacturer

AMERICAN BIO MEDICA CORP.

Date Cleared

2000-11-16

(99 days)

Product Code

DKZ,DIO,DIS,DJC,DJG,JXM,LCM,LDJ,LFI

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

K012159,K021006,K021114

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

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AI/ML Overview

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