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FDA 510(k)

WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER

K-Number: K953116 · 1996-05-13

ApplicantIntl. Remote Imaging Systems
Decision Date1996-05-13
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Remote Imaging Systems. It received FDA 510(k) clearance on 1996-05-13 under 510(k) number K953116. 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 WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER?

WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER is a medical device that received FDA 510(k) clearance on 1996-05-13. The listed applicant is Intl. Remote Imaging Systems. The 510(k) number is K953116.

When did WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER receive FDA 510(k) clearance?

WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER received FDA 510(k) clearance on 1996-05-13, under 510(k) number K953116.

Who is the listed applicant for WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER?

The FDA 510(k) record lists Intl. Remote Imaging Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER?

The FDA product code for WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER is GKZ.

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Other records listing Intl. Remote Imaging Systems 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.

K022774IQ 200 SYSTEMK000373939UDX URINE PATHOLOGY SYSTEMK972141THE YELLOW IRIS URINALYSIS WORKSTATIONK960054900UDX URINE PATHOLOGY SYSTEMK954006YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITYK943463THE YELLOW IRIS

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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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