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FDA 510(k)

SYSMEX E-5000 FULLY AUTOMATED HEMATOLOGY SYSTEM

K-Number: K855116 · 1986-02-24

ApplicantToa Medical Electronics USA, Inc.
Decision Date1986-02-24
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SYSMEX E-5000 FULLY AUTOMATED HEMATOLOGY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Toa Medical Electronics USA, Inc.. It received FDA 510(k) clearance on 1986-02-24 under 510(k) number K855116. 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 SYSMEX E-5000 FULLY AUTOMATED HEMATOLOGY SYSTEM?

SYSMEX E-5000 FULLY AUTOMATED HEMATOLOGY SYSTEM is a medical device that received FDA 510(k) clearance on 1986-02-24. The listed applicant is Toa Medical Electronics USA, Inc.. The 510(k) number is K855116.

When did SYSMEX E-5000 FULLY AUTOMATED HEMATOLOGY SYSTEM receive FDA 510(k) clearance?

SYSMEX E-5000 FULLY AUTOMATED HEMATOLOGY SYSTEM received FDA 510(k) clearance on 1986-02-24, under 510(k) number K855116.

Who is the listed applicant for SYSMEX E-5000 FULLY AUTOMATED HEMATOLOGY SYSTEM?

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

What is the FDA product code for SYSMEX E-5000 FULLY AUTOMATED HEMATOLOGY SYSTEM?

The FDA product code for SYSMEX E-5000 FULLY AUTOMATED HEMATOLOGY SYSTEM is GKZ.

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Other records listing Toa Medical Electronics USA, 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.

K936023SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZERK933886TOA MEDICAL ELECTRONICS CA-5000K931149CA-1000 AUTOMATED COAGULATION ANALYZERK920544SYSMEX HEMATOLOGY SYSTEM ACCESSORIESK914744SYSMEX NE-1500, MODIFICATIONK912494SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER

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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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