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FDA 510(k)

COULTER CLONE B1 MONOCLONAL ANTIBODY

K-Number: K882557 · 1988-09-14

ApplicantCoulter Immunology
Decision Date1988-09-14
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COULTER CLONE B1 MONOCLONAL ANTIBODY is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Immunology. It received FDA 510(k) clearance on 1988-09-14 under 510(k) number K882557. 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 COULTER CLONE B1 MONOCLONAL ANTIBODY?

COULTER CLONE B1 MONOCLONAL ANTIBODY is a medical device that received FDA 510(k) clearance on 1988-09-14. The listed applicant is Coulter Immunology. The 510(k) number is K882557.

When did COULTER CLONE B1 MONOCLONAL ANTIBODY receive FDA 510(k) clearance?

COULTER CLONE B1 MONOCLONAL ANTIBODY received FDA 510(k) clearance on 1988-09-14, under 510(k) number K882557.

Who is the listed applicant for COULTER CLONE B1 MONOCLONAL ANTIBODY?

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 COULTER CLONE B1 MONOCLONAL ANTIBODY?

The FDA product code for COULTER CLONE B1 MONOCLONAL ANTIBODY 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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