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510(k) Data Aggregation

K Number

Device Name

BAYER RAPIDPOINT 400 SYSTEM

Manufacturer

Date Cleared

2000-12-19

(109 days)

Product Code

CHL,CEM,CGA,CGZ,GKF,JFP,JGS

Regulation Number

Type

Panel

Clinical Chemistry

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

BAYER RAPIDPOINT 400 SYSTEM

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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