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FDA 510(k)

SYSMEX CC-800/PDA-410 W/TRI-MODAL LEUKOCYTE SIZE -

K-Number: K844910 · 1985-04-01

ApplicantToa Medical Electronics USA, Inc.
Decision Date1985-04-01
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SYSMEX CC-800/PDA-410 W/TRI-MODAL LEUKOCYTE SIZE - 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 1985-04-01 under 510(k) number K844910. 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 CC-800/PDA-410 W/TRI-MODAL LEUKOCYTE SIZE -?

SYSMEX CC-800/PDA-410 W/TRI-MODAL LEUKOCYTE SIZE - is a medical device that received FDA 510(k) clearance on 1985-04-01. The listed applicant is Toa Medical Electronics USA, Inc.. The 510(k) number is K844910.

When did SYSMEX CC-800/PDA-410 W/TRI-MODAL LEUKOCYTE SIZE - receive FDA 510(k) clearance?

SYSMEX CC-800/PDA-410 W/TRI-MODAL LEUKOCYTE SIZE - received FDA 510(k) clearance on 1985-04-01, under 510(k) number K844910.

Who is the listed applicant for SYSMEX CC-800/PDA-410 W/TRI-MODAL LEUKOCYTE SIZE -?

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 CC-800/PDA-410 W/TRI-MODAL LEUKOCYTE SIZE -?

The FDA product code for SYSMEX CC-800/PDA-410 W/TRI-MODAL LEUKOCYTE SIZE - is GKZ.

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Other records listing Toa Medical Electronics USA, Inc. as applicant

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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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