GLUCOMETER M BLOOD GULCOSE METER

Glucose Oxidase, Glucose

MILES LABORATORIES, INC.

The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Glucometer M Blood Gulcose Meter.

Pre-market Notification Details

Device IDK855202
510k NumberK855202
Device Name:GLUCOMETER M BLOOD GULCOSE METER
ClassificationGlucose Oxidase, Glucose
Applicant MILES LABORATORIES, INC. 1127 MYRTLE ST. P.O. BOX 40 Elkhart,  IN  46514
ContactJohn Engelmann
CorrespondentJohn Engelmann
MILES LABORATORIES, INC. 1127 MYRTLE ST. P.O. BOX 40 Elkhart,  IN  46514
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-26
Decision Date1986-07-02

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