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510(k) Data Aggregation

K Number

Device Name

'RAPIDTEC 4' TEST

Manufacturer

AMERICAN BIO MEDICA CORP.

Date Cleared

2004-11-03

(133 days)

Product Code

DIS,DJG,DJR,JXM,JXN,LFG

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

'RAPIDTEC 4' TEST

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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