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510(k) Data Aggregation

K Number

Device Name

IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER

Manufacturer

Date Cleared

1997-04-08

(81 days)

Product Code

JJE,CGJ,DHB,JHR,JLW,KLS

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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