ABX MICROS CRP

Counter, Differential Cell

ABX DIAGNOSTICS

The following data is part of a premarket notification filed by Abx Diagnostics with the FDA for Abx Micros Crp.

Pre-market Notification Details

Device IDK002646
510k NumberK002646
Device Name:ABX MICROS CRP
ClassificationCounter, Differential Cell
Applicant ABX DIAGNOSTICS 34 BUNSEN DR. Irvine,  CA  92618 -4210
ContactBruce Davis
CorrespondentBruce Davis
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 Received2000-08-24
Decision Date2000-10-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03610230004487 K002646 000

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