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FDA 510(k)

SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS

K-Number: K850171 · 1985-05-13

ApplicantToa Medical Electronics USA, Inc.
Decision Date1985-05-13
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS 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 1985-05-13 under 510(k) number K850171. The device is classified under product code GKL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS?

SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS is a medical device that received FDA 510(k) clearance on 1985-05-13. The listed applicant is Toa Medical Electronics USA, Inc.. The 510(k) number is K850171.

When did SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS receive FDA 510(k) clearance?

SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS received FDA 510(k) clearance on 1985-05-13, under 510(k) number K850171.

Who is the listed applicant for SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS?

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-3000, FULLY AUTOMATED HEMATOLOGY SYS?

The FDA product code for SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS is GKL.

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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: GKL)

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.

K152776Glocyte Automated Cell Counter SystemAdvanced Instruments, Inc.K091539IQ 200 URINE ANALIZER BODY FLUIDS MODULEIris DiagnosticsK071652HEMOCUE WBC SYSTEMHemocue ABK051693MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEMBayer Healthcare, LLCK050235IQ 200 URINE ANALYZER BODY FLUIDS MODULEIris International, Inc.K032677SYSMEX POCH-100ISysmex 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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