COULTER 5P CONTROL

Counter, Differential Cell

COULTER ELECTRONICS, INC.

The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Coulter 5p Control.

Pre-market Notification Details

Device IDK885028
510k NumberK885028
Device Name:COULTER 5P CONTROL
ClassificationCounter, Differential Cell
Applicant COULTER ELECTRONICS, INC. 745 WEST 83RD ST. Hialeah,  FL  33014
ContactA Richardson-jones
CorrespondentA Richardson-jones
COULTER ELECTRONICS, INC. 745 WEST 83RD ST. Hialeah,  FL  33014
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-12-05
Decision Date1989-02-16

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