PRECISION Q I D BLOOD GLUCOSE TEST STRIPS

Glucose Oxidase, Glucose

MEDISENSE, INC.

The following data is part of a premarket notification filed by Medisense, Inc. with the FDA for Precision Q I D Blood Glucose Test Strips.

Pre-market Notification Details

Device IDK945887
510k NumberK945887
Device Name:PRECISION Q I D BLOOD GLUCOSE TEST STRIPS
ClassificationGlucose Oxidase, Glucose
Applicant MEDISENSE, INC. 266 SECOND AVE. Waltham,  MA  02154
ContactMichael G Halpin
CorrespondentMichael G Halpin
MEDISENSE, INC. 266 SECOND AVE. Waltham,  MA  02154
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-12-01
Decision Date1995-03-23

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