DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080

System, Test, Blood Glucose, Over The Counter

BAYER HEALTHCARE, LLC

The following data is part of a premarket notification filed by Bayer Healthcare, Llc with the FDA for Didget Blood Glucose Meter, Model 6181; Contour Blood Glucose Test Strips, Model 7080.

Pre-market Notification Details

Device IDK090628
510k NumberK090628
Device Name:DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant BAYER HEALTHCARE, LLC 777 OLD SAW MILL RIVER ROAD Tarrytown,  NY  10591
ContactSusan Brocchi
CorrespondentSusan Brocchi
BAYER HEALTHCARE, LLC 777 OLD SAW MILL RIVER ROAD Tarrytown,  NY  10591
Product CodeNBW  
Subsequent Product CodeJJX
Subsequent Product CodeLFR
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-03-09
Decision Date2009-12-04
Summary:summary

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