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FDA 510(k)

ABX PENTRA 400 : CRP

K-Number: K061138 · 2006-09-29

ApplicantHoriba Abx
Decision Date2006-09-29
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ABX PENTRA 400 : CRP is the device name listed in this FDA 510(k) record. The listed applicant is Horiba Abx. It received FDA 510(k) clearance on 2006-09-29 under 510(k) number K061138. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABX PENTRA 400 : CRP?

ABX PENTRA 400 : CRP is a medical device that received FDA 510(k) clearance on 2006-09-29. The listed applicant is Horiba Abx. The 510(k) number is K061138.

When did ABX PENTRA 400 : CRP receive FDA 510(k) clearance?

ABX PENTRA 400 : CRP received FDA 510(k) clearance on 2006-09-29, under 510(k) number K061138.

Who is the listed applicant for ABX PENTRA 400 : CRP?

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 400 : CRP?

The FDA product code for ABX PENTRA 400 : CRP is DCK.

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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: DCK)

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.

K242170K-ASSAY CRP (Ver.2)Kamiya Biomedical Company, LLCK201256Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeProcise DiagnosticsK192028Yumizen C1200 CRPHORIBA ABX SASK192118CRP VarioSENTINEL CH. SpAK191993Yumizen C1200 CRPHORIBA ABX SASK160712VITROS Chemistry Products hsCRP ReagentOrtho Clinical Diagnostics

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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