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FDA 510(k)

SYSMEX CC-800

K-Number: K821575 · 1982-07-02

ApplicantSysmex/Toa Medical Electronics, Inc.
Decision Date1982-07-02
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SYSMEX CC-800 is the device name listed in this FDA 510(k) record. The listed applicant is Sysmex/Toa Medical Electronics, Inc.. It received FDA 510(k) clearance on 1982-07-02 under 510(k) number K821575. 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 CC-800?

SYSMEX CC-800 is a medical device that received FDA 510(k) clearance on 1982-07-02. The listed applicant is Sysmex/Toa Medical Electronics, Inc.. The 510(k) number is K821575.

When did SYSMEX CC-800 receive FDA 510(k) clearance?

SYSMEX CC-800 received FDA 510(k) clearance on 1982-07-02, under 510(k) number K821575.

Who is the listed applicant for SYSMEX CC-800?

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

What is the FDA product code for SYSMEX CC-800?

The FDA product code for SYSMEX CC-800 is GKL.

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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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