On Call Express II Blood Glucose Monitoring System

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 Express Ii Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK192175
510k NumberK192175
Device Name:On Call Express II Blood Glucose Monitoring System
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant ACON Laboratories, Inc. 10125 Mesa Rim Road San Diego,  CA  92121
ContactQiyi Xie
CorrespondentQiyi Xie
ACON Laboratories, Inc. 10125 Mesa Rim Road San Diego,  CA  92121
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-12
Decision Date2019-10-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00682607001675 K192175 000
20682607571141 K192175 000

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