ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM

Glucose Oxidase, Glucose

LIFESCAN, INC.

The following data is part of a premarket notification filed by Lifescan, Inc. with the FDA for One Touch Ii Hospital Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK974451
510k NumberK974451
Device Name:ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
ClassificationGlucose Oxidase, Glucose
Applicant LIFESCAN, INC. 1000 GIBRALTAR DR. Milpitas,  CA  95035 -6312
ContactLori D Conzen
CorrespondentLori D Conzen
LIFESCAN, INC. 1000 GIBRALTAR DR. Milpitas,  CA  95035 -6312
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-11-25
Decision Date1998-01-26
Summary:summary

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