COULTER MH009

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 Mh009.

Pre-market Notification Details

Device IDK922181
510k NumberK922181
Device Name:COULTER MH009
ClassificationCounter, Differential Cell
Applicant COULTER ELECTRONICS, INC. 745 WEST 83RD ST. Hialeah,  FL  33014
ContactRichardson-jones
CorrespondentRichardson-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 Received1992-05-08
Decision Date1992-08-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.