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FDA 510(k)

COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632

K-Number: K011342 · 2001-07-09

ApplicantBeckman Coulter, Inc.
Decision Date2001-07-09
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2001-07-09 under 510(k) number K011342. 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 COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632?

COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 is a medical device that received FDA 510(k) clearance on 2001-07-09. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K011342.

When did COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 receive FDA 510(k) clearance?

COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 received FDA 510(k) clearance on 2001-07-09, under 510(k) number K011342.

Who is the listed applicant for COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632?

The FDA 510(k) record lists Beckman Coulter, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632?

The FDA product code for COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 is GKZ.

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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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