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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K193340
Device Name GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System
Applicant
MicroTech Medical, Inc.
3350 Scott Blvd, Bldg.64
Santa Clara,  CA  95045
Applicant Contact Dore Mark
Correspondent
Zi-Medical, Inc
253 Summer St
Somerville,  MA  02143
Correspondent Contact Mingzi Hussey
Regulation Number862.1345
Classification Product Code
NBW  
Date Received12/02/2019
Decision Date 09/11/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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