ECLIPSE ICA GLUCOSE

Hexokinase, Glucose

BIOTOPE, INC.

The following data is part of a premarket notification filed by Biotope, Inc. with the FDA for Eclipse Ica Glucose.

Pre-market Notification Details

Device IDK905144
510k NumberK905144
Device Name:ECLIPSE ICA GLUCOSE
ClassificationHexokinase, Glucose
Applicant BIOTOPE, INC. 12277 134TH CT., N.E. Redmond,  WA  98052
ContactLynn Shanta
CorrespondentLynn Shanta
BIOTOPE, INC. 12277 134TH CT., N.E. Redmond,  WA  98052
Product CodeCFR  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-11-15
Decision Date1991-01-04

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