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Found 2 results

510(k) Data Aggregation

K Number

Device Name

MEDONIC M SERIES

Manufacturer

BOULE MEDICAL AB

Date Cleared

2009-02-03

(76 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

BOULE MEDICAL AB

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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K Number

Device Name

MEDONIC CA620/530 HEMATOLOGY ANALYZER

Manufacturer

BOULE MEDICAL AB

Date Cleared

2004-01-29

(192 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

BOULE MEDICAL AB

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The Medonic CA620/530 is a fully automated hematology analyzer used for in vitro diagnostic testing of whole blood specimens. Automated differential cell counters are used to identify and classify one or more populations of formed elements in whole blood specimens

Device Description

Not Found

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