INTOUCH DIABETES

System, Test, Blood Glucose, Over The Counter

SYMCARE PERSONALIZED HEALTH SOLUTIONS, INC

The following data is part of a premarket notification filed by Symcare Personalized Health Solutions, Inc with the FDA for Intouch Diabetes.

Pre-market Notification Details

Device IDK093789
510k NumberK093789
Device Name:INTOUCH DIABETES
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant SYMCARE PERSONALIZED HEALTH SOLUTIONS, INC 965 CHESTERBROOK BLVD Wayne,  PA  19087
ContactRae Ann Delay
CorrespondentRae Ann Delay
SYMCARE PERSONALIZED HEALTH SOLUTIONS, INC 965 CHESTERBROOK BLVD Wayne,  PA  19087
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-09
Decision Date2010-02-19
Summary:summary

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