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FDA 510(k)

MEDONIC CA620/530 HEMATOLOGY ANALYZER

K-Number: K032214 · 2004-01-29

ApplicantBoule Medical AB
Decision Date2004-01-29
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MEDONIC CA620/530 HEMATOLOGY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Boule Medical AB. It received FDA 510(k) clearance on 2004-01-29 under 510(k) number K032214. 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 MEDONIC CA620/530 HEMATOLOGY ANALYZER?

MEDONIC CA620/530 HEMATOLOGY ANALYZER is a medical device that received FDA 510(k) clearance on 2004-01-29. The listed applicant is Boule Medical AB. The 510(k) number is K032214.

When did MEDONIC CA620/530 HEMATOLOGY ANALYZER receive FDA 510(k) clearance?

MEDONIC CA620/530 HEMATOLOGY ANALYZER received FDA 510(k) clearance on 2004-01-29, under 510(k) number K032214.

Who is the listed applicant for MEDONIC CA620/530 HEMATOLOGY ANALYZER?

The FDA 510(k) record lists Boule Medical AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDONIC CA620/530 HEMATOLOGY ANALYZER?

The FDA product code for MEDONIC CA620/530 HEMATOLOGY ANALYZER is GKZ.

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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.

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Other records listing Boule Medical AB 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.

K083420MEDONIC M SERIES

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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