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510(k) Data Aggregation

K Number

Device Name

ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565

Manufacturer

BECKMAN COULTER, INC.

Date Cleared

2000-08-22

(57 days)

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Regulation Number

Type

Panel

Clinical Chemistry

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N/A

Why did this record match?

Device Name :

ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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