Bioland Blood Glucose Monitoring System

System, Test, Blood Glucose, Over The Counter

Bioland Technology Ltd.

The following data is part of a premarket notification filed by Bioland Technology Ltd. with the FDA for Bioland Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK191657
510k NumberK191657
Device Name:Bioland Blood Glucose Monitoring System
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant Bioland Technology Ltd. No. A6B7 (Block G), ShangRong Industrial Zone, No. 5 Baolong Road Baolong Community, Longgang District, Sh,  CN 518116
ContactKe-min Jen
CorrespondentKe-min Jen
Bioland Technology Ltd. No. A6B7 (Block G), ShangRong Industrial Zone No. 5 Baolong Road Baolong Community, Longgang District, Sh,  CN 518116
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyClinical Chemistry
510k Review PanelClinical Chemistry
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-21
Decision Date2020-03-20

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