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Found 2 results

510(k) Data Aggregation

K Number

Device Name

MS 4/5 HEMATOLOGY ANALYZER

Manufacturer

MELET SCHLOESING LABORATORIES USA

Date Cleared

2005-08-31

(194 days)

Product Code

GKZ

Regulation Number

864.5220

Why did this record match?

Applicant Name (Manufacturer) :

MELET SCHLOESING LABORATORIES USA

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The MS 4/5 is a quantitative, automated hematology analyzer that provides a leukocyte differential for in vitro diagnostic use in clinical laboratories.

Device Description

Not Found

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K Number

Device Name

MS 9/5 HEMATOLOGY ANALYZER

Manufacturer

MELET SCHLOESING LABORATORIES USA

Date Cleared

2005-07-27

(155 days)

Product Code

GKZ

Regulation Number

864.5220

Why did this record match?

Applicant Name (Manufacturer) :

MELET SCHLOESING LABORATORIES USA

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The MS 9/5 is a quantitative, automated hematology analyzer that provides a leukocyte differential count for In-Vitro diagnostic use in clinical laboratories.

Device Description

Not Found

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