ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM

Glucose Oxidase, Glucose

ACON LABORATORIES, INC.

The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for On Call Chosen Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK111371
510k NumberK111371
Device Name:ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM
ClassificationGlucose Oxidase, Glucose
Applicant ACON LABORATORIES, INC. 10125 MESA RIM RD. San Diego,  CA  92121
ContactQiyi Xie
CorrespondentQiyi Xie
ACON LABORATORIES, INC. 10125 MESA RIM RD. San Diego,  CA  92121
Product CodeCGA  
Subsequent Product CodeJJX
Subsequent Product CodeNBW
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-05-16
Decision Date2011-10-06
Summary:summary

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