MODIFICATION TO PENTRA 60 AND PENTRA 60C+

Counter, Differential Cell

ABX DIAGNOSTICS

The following data is part of a premarket notification filed by Abx Diagnostics with the FDA for Modification To Pentra 60 And Pentra 60c+.

Pre-market Notification Details

Device IDK030144
510k NumberK030144
Device Name:MODIFICATION TO PENTRA 60 AND PENTRA 60C+
ClassificationCounter, Differential Cell
Applicant ABX DIAGNOSTICS PARC EUROMEDECINE RUE DU CADUCEE Monpellier,  FR 34184
ContactTim Lawton
CorrespondentTim Lawton
ABX DIAGNOSTICS PARC EUROMEDECINE RUE DU CADUCEE Monpellier,  FR 34184
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-01-15
Decision Date2003-01-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03610230006429 K030144 000
03610230006412 K030144 000
03610230006016 K030144 000
03610230006009 K030144 000

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