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FDA 510(k)

ABX PENTRA 60 HEMATOLOGY ANALYZER

K-Number: K992511 · 1999-10-15

ApplicantAbx Diagnostics
Decision Date1999-10-15
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ABX PENTRA 60 HEMATOLOGY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Abx Diagnostics. It received FDA 510(k) clearance on 1999-10-15 under 510(k) number K992511. 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 60 HEMATOLOGY ANALYZER?

ABX PENTRA 60 HEMATOLOGY ANALYZER is a medical device that received FDA 510(k) clearance on 1999-10-15. The listed applicant is Abx Diagnostics. The 510(k) number is K992511.

When did ABX PENTRA 60 HEMATOLOGY ANALYZER receive FDA 510(k) clearance?

ABX PENTRA 60 HEMATOLOGY ANALYZER received FDA 510(k) clearance on 1999-10-15, under 510(k) number K992511.

Who is the listed applicant for ABX PENTRA 60 HEMATOLOGY ANALYZER?

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 ABX PENTRA 60 HEMATOLOGY ANALYZER?

The FDA product code for ABX PENTRA 60 HEMATOLOGY ANALYZER 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+K024002PENTRA 80K022200PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120K014203ABX MICROS 60 HEMATOLOGY ANALYZERK003677ABX PENTRA 60C+ HEMATOLOGY 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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