ON CALL PLUS DIABETES MONITORING SOFTWARE

System, Test, Blood Glucose, Over The Counter

ACON LABORATORIES, INC.

The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for On Call Plus Diabetes Monitoring Software.

Pre-market Notification Details

Device IDK101371
510k NumberK101371
Device Name:ON CALL PLUS DIABETES MONITORING SOFTWARE
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant ACON LABORATORIES, INC. 10125 MESA RIM RD. San Diego,  CA  92121
ContactRichard Lenart
CorrespondentRichard Lenart
ACON LABORATORIES, INC. 10125 MESA RIM RD. San Diego,  CA  92121
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-05-17
Decision Date2011-01-07
Summary:summary

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