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Found 1 results

510(k) Data Aggregation

K Number

Validate with FDA (Live)

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

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K031560,K151978

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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