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FDA 510(k)

ABX PENTRA DX 120: OPTION SPS EVOLUTION

K-Number: K050719 · 2005-04-26

ApplicantHoriba Abx
Decision Date2005-04-26
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ABX PENTRA DX 120: OPTION SPS EVOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Horiba Abx. It received FDA 510(k) clearance on 2005-04-26 under 510(k) number K050719. 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 ABX PENTRA DX 120: OPTION SPS EVOLUTION?

ABX PENTRA DX 120: OPTION SPS EVOLUTION is a medical device that received FDA 510(k) clearance on 2005-04-26. The listed applicant is Horiba Abx. The 510(k) number is K050719.

When did ABX PENTRA DX 120: OPTION SPS EVOLUTION receive FDA 510(k) clearance?

ABX PENTRA DX 120: OPTION SPS EVOLUTION received FDA 510(k) clearance on 2005-04-26, under 510(k) number K050719.

Who is the listed applicant for ABX PENTRA DX 120: OPTION SPS EVOLUTION?

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

What is the FDA product code for ABX PENTRA DX 120: OPTION SPS EVOLUTION?

The FDA product code for ABX PENTRA DX 120: OPTION SPS EVOLUTION is GKZ.

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Other records listing Horiba Abx 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.

K073309ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENTK081276ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/HK071779ABX PENTRA URINE CALK072115ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/HK070146ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CPK062737CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER

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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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