GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System

System, Test, Blood Glucose, Over The Counter

MicroTech Medical, Inc.

The following data is part of a premarket notification filed by Microtech Medical, Inc. with the FDA for Gochek Blood Glucose Monitoring System, Gochek Connect Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK193340
510k NumberK193340
Device Name:GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant MicroTech Medical, Inc. 3350 Scott Blvd, Bldg.64 Santa Clara,  CA  95045
ContactDore Mark
CorrespondentMingzi Hussey
Zi-Medical, Inc 253 Summer St Somerville,  MA  02143
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-02
Decision Date2020-09-11

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