SIDEKICK BLOOD GLUCOSE TEST 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 Sidekick Blood Glucose Test System.

Pre-market Notification Details

Device IDK051147
510k NumberK051147
Device Name:SIDEKICK BLOOD GLUCOSE TEST 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 Received2005-05-04
Decision Date2005-07-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10021292012707 K051147 000
10681131130315 K051147 000

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