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FDA 510(k)

CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY

K-Number: K903665 · 1990-10-04

ApplicantUnipath , Ltd.
Decision Date1990-10-04
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY is the device name listed in this FDA 510(k) record. The listed applicant is Unipath , Ltd.. It received FDA 510(k) clearance on 1990-10-04 under 510(k) number K903665. 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 CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY?

CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY is a medical device that received FDA 510(k) clearance on 1990-10-04. The listed applicant is Unipath , Ltd.. The 510(k) number is K903665.

When did CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY receive FDA 510(k) clearance?

CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY received FDA 510(k) clearance on 1990-10-04, under 510(k) number K903665.

Who is the listed applicant for CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY?

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

What is the FDA product code for CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY?

The FDA product code for CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY is GKZ.

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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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