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510(k) Data Aggregation

K Number

Device Name

ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479

Manufacturer

BECKMAN COULTER, INC.

Date Cleared

2001-06-13

(238 days)

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Regulation Number

Type

Panel

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N/A

Why did this record match?

Device Name :

ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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