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FDA 510(k)

COULTER Z 1

K-Number: K952308 · 1995-10-06

ApplicantCoulter Corp.
Decision Date1995-10-06
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COULTER Z 1 is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Corp.. It received FDA 510(k) clearance on 1995-10-06 under 510(k) number K952308. The device is classified under product code GKL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COULTER Z 1?

COULTER Z 1 is a medical device that received FDA 510(k) clearance on 1995-10-06. The listed applicant is Coulter Corp.. The 510(k) number is K952308.

When did COULTER Z 1 receive FDA 510(k) clearance?

COULTER Z 1 received FDA 510(k) clearance on 1995-10-06, under 510(k) number K952308.

Who is the listed applicant for COULTER Z 1?

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 COULTER Z 1?

The FDA product code for COULTER Z 1 is GKL.

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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: GKL)

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.

K152776Glocyte Automated Cell Counter SystemAdvanced Instruments, Inc.K091539IQ 200 URINE ANALIZER BODY FLUIDS MODULEIris DiagnosticsK071652HEMOCUE WBC SYSTEMHemocue ABK051693MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEMBayer Healthcare, LLCK050235IQ 200 URINE ANALYZER BODY FLUIDS MODULEIris International, Inc.K032677SYSMEX POCH-100ISysmex 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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