I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM

System, Test, Blood Glucose, Over The Counter

ALLIANCE INTERNATIONAL CO., LTD.

The following data is part of a premarket notification filed by Alliance International Co., Ltd. with the FDA for I-qare Ds-w Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK132663
510k NumberK132663
Device Name:I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant ALLIANCE INTERNATIONAL CO., LTD. NO.54 YING TAO RD. YING DISTRICT New Taipei City, 239,  TW 23942
ContactJen Ke-min
CorrespondentJen Ke-min
ALLIANCE INTERNATIONAL CO., LTD. NO.54 YING TAO RD. YING DISTRICT New Taipei City, 239,  TW 23942
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-26
Decision Date2015-04-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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16971292007019 K132663 000
16971292007002 K132663 000
16971292006999 K132663 000
06971292006985 K132663 000
16971292003134 K132663 000

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