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FDA 510(k)

COULTER MH015 (DIFFERENTIAL CELL COUNTER)

K-Number: K930913 · 1993-08-23

ApplicantCoulter Corp.
Decision Date1993-08-23
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COULTER MH015 (DIFFERENTIAL CELL COUNTER) is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Corp.. It received FDA 510(k) clearance on 1993-08-23 under 510(k) number K930913. 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 MH015 (DIFFERENTIAL CELL COUNTER)?

COULTER MH015 (DIFFERENTIAL CELL COUNTER) is a medical device that received FDA 510(k) clearance on 1993-08-23. The listed applicant is Coulter Corp.. The 510(k) number is K930913.

When did COULTER MH015 (DIFFERENTIAL CELL COUNTER) receive FDA 510(k) clearance?

COULTER MH015 (DIFFERENTIAL CELL COUNTER) received FDA 510(k) clearance on 1993-08-23, under 510(k) number K930913.

Who is the listed applicant for COULTER MH015 (DIFFERENTIAL CELL COUNTER)?

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 MH015 (DIFFERENTIAL CELL COUNTER)?

The FDA product code for COULTER MH015 (DIFFERENTIAL CELL COUNTER) 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

View all 51 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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