COULTER FLOW SET

Mixture, Hematology Quality Control

COULTER CORP.

The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Coulter Flow Set.

Pre-market Notification Details

Device IDK944751
510k NumberK944751
Device Name:COULTER FLOW SET
ClassificationMixture, Hematology Quality Control
Applicant COULTER CORP. P.O. BOX 1690 Hialeah,  FL  33011 -1690
ContactThomad J English
CorrespondentThomad J English
COULTER CORP. P.O. BOX 1690 Hialeah,  FL  33011 -1690
Product CodeJPK  
CFR Regulation Number864.8625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-26
Decision Date1994-12-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590538163 K944751 000

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