ABX PENTRA 60 HEMATOLOGY ANALYZER

Counter, Differential Cell

ABX DIAGNOSTICS

The following data is part of a premarket notification filed by Abx Diagnostics with the FDA for Abx Pentra 60 Hematology Analyzer.

Pre-market Notification Details

Device IDK992511
510k NumberK992511
Device Name:ABX PENTRA 60 HEMATOLOGY ANALYZER
ClassificationCounter, Differential Cell
Applicant ABX DIAGNOSTICS 34 BUNSEN DR. Irvine,  CA  92618 -4210
ContactPat Amtower
CorrespondentPat Amtower
ABX DIAGNOSTICS 34 BUNSEN DR. Irvine,  CA  92618 -4210
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-07-27
Decision Date1999-10-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590578787 K992511 000
15099590576462 K992511 000

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