GLUCOSCAN METER MODEL II

Glucose Oxidase, Glucose

LIFESCAN, INC.

The following data is part of a premarket notification filed by Lifescan, Inc. with the FDA for Glucoscan Meter Model Ii.

Pre-market Notification Details

Device IDK822699
510k NumberK822699
Device Name:GLUCOSCAN METER MODEL II
ClassificationGlucose Oxidase, Glucose
Applicant LIFESCAN, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-09-07
Decision Date1982-11-05

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