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FDA 510(k)

ABX PENTRA 400: LIPOPROTEINS

K-Number: K060854 · 2006-08-24

ApplicantHoriba Abx
Decision Date2006-08-24
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABX PENTRA 400: LIPOPROTEINS is the device name listed in this FDA 510(k) record. The listed applicant is Horiba Abx. It received FDA 510(k) clearance on 2006-08-24 under 510(k) number K060854. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABX PENTRA 400: LIPOPROTEINS?

ABX PENTRA 400: LIPOPROTEINS is a medical device that received FDA 510(k) clearance on 2006-08-24. The listed applicant is Horiba Abx. The 510(k) number is K060854.

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

ABX PENTRA 400: LIPOPROTEINS received FDA 510(k) clearance on 2006-08-24, under 510(k) number K060854.

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

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: LIPOPROTEINS?

The FDA product code for ABX PENTRA 400: LIPOPROTEINS is JIT.

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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: JIT)

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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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