FreeStyle Precision Neo Blood Glucose Test Strips

System, Test, Blood Glucose, Over The Counter

Abbott Diabetes Care Inc.

The following data is part of a premarket notification filed by Abbott Diabetes Care Inc. with the FDA for Freestyle Precision Neo Blood Glucose Test Strips.

Pre-market Notification Details

Device IDK171941
510k NumberK171941
Device Name:FreeStyle Precision Neo Blood Glucose Test Strips
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant Abbott Diabetes Care Inc. 1360 South Loop Road Alameda,  CA  94502
ContactDanielle Tayor
CorrespondentStephanie Yun
Abbott Diabetes Care Inc. 1360 South Loop Road Alameda,  CA  94502
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-28
Decision Date2017-09-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30357599000357 K171941 000
30357599000340 K171941 000
30357599000333 K171941 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.