COULTER VISCOMETER II

Plasma Viscometer For Clinical Use

COULTER ELECTRONICS, INC.

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

Pre-market Notification Details

Device IDK883503
510k NumberK883503
Device Name:COULTER VISCOMETER II
ClassificationPlasma Viscometer For Clinical Use
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 CodeJJL  
CFR Regulation Number862.2920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-08-17
Decision Date1988-09-19

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