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FDA 510(k)

PENTRA 80

K-Number: K024002 · 2003-01-03

ApplicantAbx Diagnostics
Decision Date2003-01-03
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PENTRA 80 is the device name listed in this FDA 510(k) record. The listed applicant is Abx Diagnostics. It received FDA 510(k) clearance on 2003-01-03 under 510(k) number K024002. 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 PENTRA 80?

PENTRA 80 is a medical device that received FDA 510(k) clearance on 2003-01-03. The listed applicant is Abx Diagnostics. The 510(k) number is K024002.

When did PENTRA 80 receive FDA 510(k) clearance?

PENTRA 80 received FDA 510(k) clearance on 2003-01-03, under 510(k) number K024002.

Who is the listed applicant for PENTRA 80?

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

What is the FDA product code for PENTRA 80?

The FDA product code for PENTRA 80 is GKZ.

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Other records listing Abx Diagnostics 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.

K030799MICROS 60K030144MODIFICATION TO PENTRA 60 AND PENTRA 60C+K022200PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120K014203ABX MICROS 60 HEMATOLOGY ANALYZERK003677ABX PENTRA 60C+ HEMATOLOGY ANALYZERK002646ABX MICROS CRP

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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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