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FDA 510(k)

CELLEXIS HEMATOLOGY ANALYZER

K-Number: K923773 · 1993-02-05

ApplicantTechnalysis, Inc.
Decision Date1993-02-05
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CELLEXIS HEMATOLOGY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Technalysis, Inc.. It received FDA 510(k) clearance on 1993-02-05 under 510(k) number K923773. 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 CELLEXIS HEMATOLOGY ANALYZER?

CELLEXIS HEMATOLOGY ANALYZER is a medical device that received FDA 510(k) clearance on 1993-02-05. The listed applicant is Technalysis, Inc.. The 510(k) number is K923773.

When did CELLEXIS HEMATOLOGY ANALYZER receive FDA 510(k) clearance?

CELLEXIS HEMATOLOGY ANALYZER received FDA 510(k) clearance on 1993-02-05, under 510(k) number K923773.

Who is the listed applicant for CELLEXIS HEMATOLOGY ANALYZER?

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

What is the FDA product code for CELLEXIS HEMATOLOGY ANALYZER?

The FDA product code for CELLEXIS HEMATOLOGY ANALYZER is GKZ.

Related Clinical Trials

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 Technalysis, Inc. 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.

K905600TECHLYTE ELECTROLYTE ANALYZERK885091HEMAVIEW DARKFIELD MICROSCOPE SYSTEM

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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