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FDA 510(k)

MS 4/5 HEMATOLOGY ANALYZER

K-Number: K050421 · 2005-08-31

ApplicantMelet Schloesing Laboratories USA
Decision Date2005-08-31
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MS 4/5 HEMATOLOGY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Melet Schloesing Laboratories USA. It received FDA 510(k) clearance on 2005-08-31 under 510(k) number K050421. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MS 4/5 HEMATOLOGY ANALYZER?

MS 4/5 HEMATOLOGY ANALYZER is a medical device that received FDA 510(k) clearance on 2005-08-31. The listed applicant is Melet Schloesing Laboratories USA. The 510(k) number is K050421.

When did MS 4/5 HEMATOLOGY ANALYZER receive FDA 510(k) clearance?

MS 4/5 HEMATOLOGY ANALYZER received FDA 510(k) clearance on 2005-08-31, under 510(k) number K050421.

Who is the listed applicant for MS 4/5 HEMATOLOGY ANALYZER?

The FDA 510(k) record lists Melet Schloesing Laboratories USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MS 4/5 HEMATOLOGY ANALYZER?

The FDA product code for MS 4/5 HEMATOLOGY ANALYZER is GKZ.

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Other records listing Melet Schloesing Laboratories USA as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K050436MS 9/5 HEMATOLOGY ANALYZER

Related Devices (Code: GKZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260781Yumizen H550HORIBA ABX SASK253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249Tru Hematology TestTruvian Sciences, Inc.K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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