FDA 510(k)

CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER

K-Number: K062737 · 2007-06-12

Decision Date2007-06-12

Product CodeCGS

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Horiba Abx. It received FDA 510(k) clearance on 2007-06-12 under 510(k) number K062737. The device is classified under product code CGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER?

CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER is a medical device that received FDA 510(k) clearance on 2007-06-12. The listed applicant is Horiba Abx. The 510(k) number is K062737.

When did CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER receive FDA 510(k) clearance?

CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER received FDA 510(k) clearance on 2007-06-12, under 510(k) number K062737.

Who is the listed applicant for CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER?

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 CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER?

The FDA product code for CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER is CGS.

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Other records listing Horiba Abx as applicant

K073309ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT K081276ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H K071779ABX PENTRA URINE CAL K072115ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H K070146ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP K060434ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL

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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.