HEMO-W SYSTEM

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 Hemo-w System.

Pre-market Notification Details

Device IDK781628
510k NumberK781628
Device Name:HEMO-W SYSTEM
ClassificationCounter, Cell, Automated (particle Counter)
Applicant COULTER ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGKL  
CFR Regulation Number864.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-09-25
Decision Date1978-10-27

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