QUICKPRO BLOOD GLUCOSE TESTING SYSTEM

Glucose Oxidase, Glucose

MEDISENSE, INC.

The following data is part of a premarket notification filed by Medisense, Inc. with the FDA for Quickpro Blood Glucose Testing System.

Pre-market Notification Details

Device IDK944195
510k NumberK944195
Device Name:QUICKPRO BLOOD GLUCOSE TESTING SYSTEM
ClassificationGlucose Oxidase, Glucose
Applicant MEDISENSE, INC. 266 SECOND AVE. Waltham,  MA  02154
ContactJohn J Vocella
CorrespondentJohn J Vocella
MEDISENSE, INC. 266 SECOND AVE. Waltham,  MA  02154
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-29
Decision Date1995-03-23

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