Vivachek Laboratories Inc

FDA Filings

This page includes the latest FDA filings for Vivachek Laboratories Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3012355933
• FEI Number: 3012355933
• Name: VIVACHEK LABORATORIES, INC.,
• Owner & Operator: VivaChek Laboratories, Inc.,
• Contact Address: 913 N Market Street, Suite 200 ; Wilmington DE 19801 US
• Official Correspondent:
  • julie zhou
  • 1-858-3098565-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 913 N Market Street, Suite 200 ; Wilmington, DE 19801 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
PMN K173140 | NBW VIVACHEK LABORATORIES, INC.,	VivaGuard Via Talk Simple Blood Glucose Monitoring System	2019-02-21
PMN K173140 | NBW VIVACHEK LABORATORIES, INC.,	VivaGuard Via Talk Simple Blood Glucose Meter	2019-02-21
PMN K173140 | NBW VIVACHEK LABORATORIES, INC.,	VivaGuard Via Talk Bright Blood Glucose Monitoring System	2019-02-21
PMN K173140 | NBW VIVACHEK LABORATORIES, INC.,	VivaGuard Via Talk Bright Blood Glucose Meter	2019-02-21
PMN K173140 | NBW VIVACHEK LABORATORIES, INC.,	VivaGuard Via Talk Blood Glucose Monitoring System	2019-02-21
PMN K173140 | NBW VIVACHEK LABORATORIES, INC.,	VivaGuard Via Talk Blood Glucose Meter	2019-02-21
PMN K173140 | NBW VIVACHEK LABORATORIES, INC.,	VivaGuard Via Sync Blood Glucose Monitoring System	2019-02-21
PMN K173140 | NBW VIVACHEK LABORATORIES, INC.,	VivaGuard Via Sync Blood Glucose Meter	2019-02-21
PMN K173140 | NBW VIVACHEK LABORATORIES, INC.,	VivaGuard Via Smart Blood Glucose Monitoring System	2019-02-21
PMN K173140 | NBW VIVACHEK LABORATORIES, INC.,	VivaGuard Via Smart Blood Glucose Meter	2019-02-21
PMN K173140 | NBW VIVACHEK LABORATORIES, INC.,	VivaGuard Via Plus Blood Glucose Monitoring System	2019-02-21
PMN K173140 | NBW VIVACHEK LABORATORIES, INC.,	VivaGuard Via Plus Blood Glucose Meter	2019-02-21
PMN K173140 VivaChek Laboratories, Inc.	VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Moni	2018-12-19
PMN K160179 | NBW VIVACHEK LABORATORIES, INC.,	VivaGuard Via Control Solution	2017-06-23
PMN K160179 | NBW VIVACHEK LABORATORIES, INC.,	VivaGuard Via Blood Glucose Test Strips	2017-06-23
PMN K160179 | NBW VIVACHEK LABORATORIES, INC.,	VivaGuard Via Blood Glucose Monitoring System	2017-06-23
PMN K160179 | NBW VIVACHEK LABORATORIES, INC.,	VivaGuard Via Blood Glucose Meter	2017-06-23
PMN K160179 | JJX VIVACHEK LABORATORIES, INC.,	VivaGuard Via Control Solution	2017-06-23
PMN K160179 | JJX VIVACHEK LABORATORIES, INC.,	VivaGuard Via Blood Glucose Test Strips	2017-06-23
PMN K160179 | JJX VIVACHEK LABORATORIES, INC.,	VivaGuard Via Blood Glucose Monitoring System	2017-06-23
PMN K160179 | JJX VIVACHEK LABORATORIES, INC.,	VivaGuard Via Blood Glucose Meter	2017-06-23
PMN K160179 | CGA VIVACHEK LABORATORIES, INC.,	VivaGuard Via Control Solution	2017-06-23
PMN K160179 | CGA VIVACHEK LABORATORIES, INC.,	VivaGuard Via Blood Glucose Test Strips	2017-06-23
PMN K160179 | CGA VIVACHEK LABORATORIES, INC.,	VivaGuard Via Blood Glucose Monitoring System	2017-06-23
PMN K160179 | CGA VIVACHEK LABORATORIES, INC.,	VivaGuard Via Blood Glucose Meter	2017-06-23
PMN K160179 VIVACHEK LABORATORIES, INC.	VivaChek Ino Blood Glucose Monitoring System	2017-04-21