ECLIPSE ICA TRIGLYCERIDES

Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

BIOTOPE, INC.

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

Pre-market Notification Details

Device IDK905601
510k NumberK905601
Device Name:ECLIPSE ICA TRIGLYCERIDES
ClassificationLipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
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 CodeCDT  
CFR Regulation Number862.1705 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-13
Decision Date1991-01-17

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