COULTER AC.T SERIES ANALYZER

Counter, Differential Cell

COULTER CORP.

The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Coulter Ac.t Series Analyzer.

Pre-market Notification Details

Device IDK964988
510k NumberK964988
Device Name:COULTER AC.T SERIES ANALYZER
ClassificationCounter, Differential Cell
Applicant COULTER CORP. 11800 S.W. 147TH AVE. Miami,  FL  33196 -2500
ContactThomas J English
CorrespondentThomas J English
COULTER CORP. 11800 S.W. 147TH AVE. Miami,  FL  33196 -2500
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-12-13
Decision Date1997-03-06
Summary:summary

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