SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEM

Enzymatic Esterase--oxidase, Cholesterol

MEDISENSE, INC.

The following data is part of a premarket notification filed by Medisense, Inc. with the FDA for Satellite C Blood Cholesterol Monitoring System.

Pre-market Notification Details

Device IDK896467
510k NumberK896467
Device Name:SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEM
ClassificationEnzymatic Esterase--oxidase, Cholesterol
Applicant MEDISENSE, INC. 128 SIDNEY ST. Cambridge,  MA  02139
ContactLias, Phd
CorrespondentLias, Phd
MEDISENSE, INC. 128 SIDNEY ST. Cambridge,  MA  02139
Product CodeCHH  
CFR Regulation Number862.1175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-11-13
Decision Date1990-06-12

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