CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER

Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes

HORIBA ABX

The following data is part of a premarket notification filed by Horiba Abx with the FDA for Cardiac Markers On Abx Pentra 400 Clinical Chemistry Analyzer.

Pre-market Notification Details

Device IDK062737
510k NumberK062737
Device Name:CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
ClassificationNad Reduction/nadh Oxidation, Cpk Or Isoenzymes
Applicant HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE Montpellier, Herault,  FR 34184
ContactTim Lawton
CorrespondentTim Lawton
HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE Montpellier, Herault,  FR 34184
Product CodeCGS  
Subsequent Product CodeDDR
Subsequent Product CodeJIT
Subsequent Product CodeJIX
Subsequent Product CodeJIY
CFR Regulation Number862.1215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-09-13
Decision Date2007-06-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03610230006948 K062737 000
03610230005545 K062737 000

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