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FDA 510(k)

COULTER LH 500 HEMATOLOGY ANALYZER

K-Number: K032000 · 2003-08-13

ApplicantBeckman Coulter, Inc.
Decision Date2003-08-13
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COULTER LH 500 HEMATOLOGY ANALYZER 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 2003-08-13 under 510(k) number K032000. 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 500 HEMATOLOGY ANALYZER?

COULTER LH 500 HEMATOLOGY ANALYZER is a medical device that received FDA 510(k) clearance on 2003-08-13. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K032000.

When did COULTER LH 500 HEMATOLOGY ANALYZER receive FDA 510(k) clearance?

COULTER LH 500 HEMATOLOGY ANALYZER received FDA 510(k) clearance on 2003-08-13, under 510(k) number K032000.

Who is the listed applicant for COULTER LH 500 HEMATOLOGY ANALYZER?

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 500 HEMATOLOGY ANALYZER?

The FDA product code for COULTER LH 500 HEMATOLOGY ANALYZER 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.

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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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