FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001

System, Test, Blood Glucose, Over The Counter

ABBOTT LABORATORIES

The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Freestyle Auto-assist Software Verson 2.0 With Model Prt24238-001.

Pre-market Notification Details

Device IDK123089
510k NumberK123089
Device Name:FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant ABBOTT LABORATORIES 1360 SOUTH LOOP ROAD Alameda,  CA  94502
ContactDavid G Lambert
CorrespondentDavid G Lambert
ABBOTT LABORATORIES 1360 SOUTH LOOP ROAD Alameda,  CA  94502
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-01
Decision Date2013-04-05
Summary:summary

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