TRUEBALANCE BLOOD GLUCOSE SYSTEM

System, Test, Blood Glucose, Over The Counter

HOME DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Home Diagnostics, Inc. with the FDA for Truebalance Blood Glucose System.

Pre-market Notification Details

Device IDK090495
510k NumberK090495
Device Name:TRUEBALANCE BLOOD GLUCOSE SYSTEM
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant HOME DIAGNOSTICS, INC. 2400 N.W. 55TH CT. Fort Lauderdale,  FL  33309
ContactKaren Devincent
CorrespondentKaren Devincent
HOME DIAGNOSTICS, INC. 2400 N.W. 55TH CT. Fort Lauderdale,  FL  33309
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-02-25
Decision Date2009-03-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00021292007959 K090495 000
00021292007942 K090495 000
00021292003418 K090495 000
20212920031352 K090495 000

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