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FDA 510(k)

ABX PENTRA URINE CAL

K-Number: K071779 · 2008-03-05

ApplicantHoriba Abx
Decision Date2008-03-05
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABX PENTRA URINE CAL is the device name listed in this FDA 510(k) record. The listed applicant is Horiba Abx. It received FDA 510(k) clearance on 2008-03-05 under 510(k) number K071779. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABX PENTRA URINE CAL?

ABX PENTRA URINE CAL is a medical device that received FDA 510(k) clearance on 2008-03-05. The listed applicant is Horiba Abx. The 510(k) number is K071779.

When did ABX PENTRA URINE CAL receive FDA 510(k) clearance?

ABX PENTRA URINE CAL received FDA 510(k) clearance on 2008-03-05, under 510(k) number K071779.

Who is the listed applicant for ABX PENTRA URINE CAL?

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 URINE CAL?

The FDA product code for ABX PENTRA URINE CAL is JIX.

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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/HK072115ABX 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 ANALYZERK060434ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL

View all 19 devices →

Related Devices (Code: JIX)

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.

K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche DiagnosticsK130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroupK123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare DiagnosticsK123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott LaboratoriesK122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, 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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