MICROSPIN 24

Instrument, Hematocrit, Automated

VULCON TECHNOLOGIES

The following data is part of a premarket notification filed by Vulcon Technologies with the FDA for Microspin 24.

Pre-market Notification Details

Device IDK953519
510k NumberK953519
Device Name:MICROSPIN 24
ClassificationInstrument, Hematocrit, Automated
Applicant VULCON TECHNOLOGIES 718 MAIN ST. Grandview,  MO  64030
ContactJeff Hestand
CorrespondentJeff Hestand
VULCON TECHNOLOGIES 718 MAIN ST. Grandview,  MO  64030
Product CodeGKF  
CFR Regulation Number864.5600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-07-27
Decision Date1995-11-03

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