VISIDEX II REAGENT STRIPS

Glucose Oxidase, Glucose

MILES LABORATORIES, INC.

The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Visidex Ii Reagent Strips.

Pre-market Notification Details

Device IDK831989
510k NumberK831989
Device Name:VISIDEX II REAGENT STRIPS
ClassificationGlucose Oxidase, Glucose
Applicant MILES LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-06-21
Decision Date1983-08-08

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