GlucoLeader Enhance Blood Glucose Monitoring System

System, Test, Blood Glucose, Over The Counter

HMD BioMedical Inc.

The following data is part of a premarket notification filed by Hmd Biomedical Inc. with the FDA for Glucoleader Enhance Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK182428
510k NumberK182428
Device Name:GlucoLeader Enhance Blood Glucose Monitoring System
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant HMD BioMedical Inc. No. 181 Minsheng St., Xinpu Township Hsin Chu County,  TW 30542
ContactJen Ke-min
CorrespondentKe-min Jen
Chinese-European Industrial Research Society No. 58 Fu-Chiun St. Hsin-chu City,  TW 30067
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-06
Decision Date2019-05-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04711200722291 K182428 000
04711200723922 K182428 000
04711200724202 K182428 000
04711200724226 K182428 000
04711200724240 K182428 000
00850048540514 K182428 000
00850048540521 K182428 000
00810038634746 K182428 000
10810038634866 K182428 000
00850009854032 K182428 000
00850009854049 K182428 000
04711200722246 K182428 000
04711200723892 K182428 000

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