VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Moni

System, Test, Blood Glucose, Over The Counter

VivaChek Laboratories, Inc.

The following data is part of a premarket notification filed by Vivachek Laboratories, Inc. with the FDA for Vivachek Ino Smart Blood Glucose Monitoring System, Vivachek Ino Sync Blood Glucose Monitoring System, Vivachek Ino Sound Blood Glucose Monitoring System, Vivachek Ino Plus Blood Glucose Monitoring System, Vivachek Ino Sound Simple Blood Glucose Moni.

Pre-market Notification Details

Device IDK173140
510k NumberK173140
Device Name:VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Moni
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant VivaChek Laboratories, Inc. 913 N Market Street, Suite 200 Wilmington,  DE  19081
ContactJulie Zhou
CorrespondentJulie Zhou
VivaChek Laboratories, Inc. 913 N Market Street, Suite 200 Wilmington,  DE  19081
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-29
Decision Date2018-12-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00853483008243 K173140 000
00810115892359 K173140 000
00810115892441 K173140 000
00850042929001 K173140 000
00850042929018 K173140 000
00850042929025 K173140 000
00850042929032 K173140 000
00850042929049 K173140 000
00853483008236 K173140 000
00875011000048 K173140 000

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