PRECISION QID BLOOD GLUCOSE TEST STRIP

Glucose Oxidase, Glucose

MEDISENSE, INC.

The following data is part of a premarket notification filed by Medisense, Inc. with the FDA for Precision Qid Blood Glucose Test Strip.

Pre-market Notification Details

Device IDK962295
510k NumberK962295
Device Name:PRECISION QID BLOOD GLUCOSE TEST STRIP
ClassificationGlucose Oxidase, Glucose
Applicant MEDISENSE, INC. 266 SECOND AVE. Waltham,  MA  02154
ContactMichael Halpin
CorrespondentMichael 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 Received1996-05-16
Decision Date1996-07-26
Summary:summary

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