DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM

System, Test, Blood Glucose, Over The Counter

DELBIO INCORPORATION

The following data is part of a premarket notification filed by Delbio Incorporation with the FDA for Diacheck Smart/superior Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK113343
510k NumberK113343
Device Name:DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant DELBIO INCORPORATION 3F, NO. 252, SHANGYING ROAD GUISHAN INDUSTRIAL ZONE Taoyuan County,  TW 33341
ContactNicky Pan
CorrespondentNicky Pan
DELBIO INCORPORATION 3F, NO. 252, SHANGYING ROAD GUISHAN INDUSTRIAL ZONE Taoyuan County,  TW 33341
Product CodeNBW  
Subsequent Product CodeCGA
Subsequent Product CodeJJX
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-11-14
Decision Date2012-02-08

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