PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM

Glucose Dehydrogenase, Glucose

HMD BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Hmd Biomedical, Inc. with the FDA for Precichek Ns-101 Poct Professional Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK113314
510k NumberK113314
Device Name:PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
ClassificationGlucose Dehydrogenase, Glucose
Applicant HMD BIOMEDICAL, INC. #181 MINSHENG STREET Xinpu Township,  TW 30542
ContactWang Yunhan
CorrespondentWang Yunhan
HMD BIOMEDICAL, INC. #181 MINSHENG STREET Xinpu Township,  TW 30542
Product CodeLFR  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-11-09
Decision Date2012-11-09
Summary:summary

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