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FDA 510(k)

ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT

K-Number: K073309 · 2008-10-17

ApplicantHoriba Abx
Decision Date2008-10-17
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Horiba Abx. It received FDA 510(k) clearance on 2008-10-17 under 510(k) number K073309. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT?

ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT is a medical device that received FDA 510(k) clearance on 2008-10-17. The listed applicant is Horiba Abx. The 510(k) number is K073309.

When did ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT receive FDA 510(k) clearance?

ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT received FDA 510(k) clearance on 2008-10-17, under 510(k) number K073309.

Who is the listed applicant for ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT?

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 HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT?

The FDA product code for ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT is LCP.

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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.

K081276ABX 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 ANALYZERK060434ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL

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Related Devices (Code: LCP)

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.

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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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