GLUCOMETER DEX BLOOD GLUCOSE SYSTEM (MODIFIED)

System, Test, Blood Glucose, Over The Counter

BAYER GROUP DIAGNOSTICS

The following data is part of a premarket notification filed by Bayer Group Diagnostics with the FDA for Glucometer Dex Blood Glucose System (modified).

Pre-market Notification Details

Device IDK020210
510k NumberK020210
Device Name:GLUCOMETER DEX BLOOD GLUCOSE SYSTEM (MODIFIED)
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant BAYER GROUP DIAGNOSTICS 1884 MILES AVE. P.O. BOX 70 Elkhart,  IN  46515 -0070
ContactGeorge M Tancos
CorrespondentGeorge M Tancos
BAYER GROUP DIAGNOSTICS 1884 MILES AVE. P.O. BOX 70 Elkhart,  IN  46515 -0070
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-01-22
Decision Date2002-04-30
Summary:summary

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