COULTER COUNTER MODEL M4

Counter, Cell, Automated (particle Counter)

COULTER ELECTRONICS, INC.

The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Coulter Counter Model M4.

Pre-market Notification Details

Device IDK843303
510k NumberK843303
Device Name:COULTER COUNTER MODEL M4
ClassificationCounter, Cell, Automated (particle Counter)
Applicant COULTER ELECTRONICS, INC. 590 WEST 20TH ST. Hialeah,  FL  33010
ContactRichardson-jones
CorrespondentRichardson-jones
COULTER ELECTRONICS, INC. 590 WEST 20TH ST. Hialeah,  FL  33010
Product CodeGKL  
CFR Regulation Number864.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-08-23
Decision Date1984-12-05

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