OneTouch Verio Reflect Blood Glucose Monitoring System

System, Test, Blood Glucose, Over The Counter

LifeScan Europe GmbH

The following data is part of a premarket notification filed by Lifescan Europe Gmbh with the FDA for Onetouch Verio Reflect Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK193475
510k NumberK193475
Device Name:OneTouch Verio Reflect Blood Glucose Monitoring System
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant LifeScan Europe GmbH Gubelstrasse 34 Zug,  CH Ch-6300
ContactNiki Skelly
CorrespondentNiki Skelly
LifeScan Scotland Ltd. Beechwood Park North Inverness,  GB Iv1 3ed
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-16
Decision Date2020-02-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20353885011727 K193475 000
20353885011710 K193475 000
20353885011703 K193475 000
20353885011697 K193475 000
20353885012434 K193475 000
20353885012472 K193475 000
20353885012953 K193475 000

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