ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)

Hexokinase, Glucose

HORIBA ABX

The following data is part of a premarket notification filed by Horiba Abx with the FDA for Abx Pentra 400 Clinical Chemistry Analyzer (option: I.s.e. Module).

Pre-market Notification Details

Device IDK052007
510k NumberK052007
Device Name:ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)
ClassificationHexokinase, Glucose
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 CodeCFR  
Subsequent Product CodeCEM
Subsequent Product CodeCGZ
Subsequent Product CodeJGS
Subsequent Product CodeJIX
Subsequent Product CodeJJE
Subsequent Product CodeJJY
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-07-25
Decision Date2005-12-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03610230006757 K052007 000
03610230005217 K052007 000
03610230005880 K052007 000
03610230005897 K052007 000
03610230005903 K052007 000
03610230006528 K052007 000
03610230006535 K052007 000
03610230006542 K052007 000
03610230006559 K052007 000
03610230006740 K052007 000
03610230005200 K052007 000

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