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FDA 510(k)

CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI

K-Number: K895917 · 1989-12-29

ApplicantCoulter Immunology
Decision Date1989-12-29
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Immunology. It received FDA 510(k) clearance on 1989-12-29 under 510(k) number K895917. 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 CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI?

CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI is a medical device that received FDA 510(k) clearance on 1989-12-29. The listed applicant is Coulter Immunology. The 510(k) number is K895917.

When did CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI receive FDA 510(k) clearance?

CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI received FDA 510(k) clearance on 1989-12-29, under 510(k) number K895917.

Who is the listed applicant for CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI?

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

What is the FDA product code for CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI?

The FDA product code for CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI is GKZ.

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Other records listing Coulter Immunology 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.

K922744CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD1K922745CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD1K910473CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITCK911793COULTERCLONEK893852COULTER CLONE T4 MONOCLONAL ANTIBODYK893853COULTER CLONE T8 MONOCLONAL ANTIBODY

View all 16 devices →

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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