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FDA 510(k)

CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON

K-Number: K926124 · 1993-07-06

ApplicantCoulter Corp.
Decision Date1993-07-06
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Corp.. It received FDA 510(k) clearance on 1993-07-06 under 510(k) number K926124. 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 CD3 (IGG1)-FITC/B4-RD1 MON?

CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON is a medical device that received FDA 510(k) clearance on 1993-07-06. The listed applicant is Coulter Corp.. The 510(k) number is K926124.

When did CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON receive FDA 510(k) clearance?

CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON received FDA 510(k) clearance on 1993-07-06, under 510(k) number K926124.

Who is the listed applicant for CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON?

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

What is the FDA product code for CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON?

The FDA product code for CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON is GKZ.

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Other records listing Coulter Corp. 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.

K993356COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSESK991070COULTER Z2 ANALYZERK990327RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMSK990172TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLAK990352COULTER AC T DIFF 2 ANALYZERK984216IMMUNO-TROL CONTROL CELLS

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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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