Vivachek Biotech Hangzhou Co L T D

FDA Filings

This page includes the latest FDA filings for Vivachek Biotech Hangzhou Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3013223546
FEI Number3013223546
NameLee Mariano
Owner & OperatorVivaChek Biotech (Hangzhou) Co., Ltd
Contact AddressLevel 2, Block 2, 146 East Chaofeng Rd., 1/2/3 F, Building 1, 16 East Zhenxing Rd
Hangzhou CN-33 Zhejiang 311100 CN
Official Correspondent
  • Mark Qian
  • 86-571-89189521-x
US Agent
  • Lee Mariano
  • 302 3398107
  • 302 3398107
  • lmariano@ablediagnostics.com
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address12396 World Trade Drive, Suite 216
San Diego, CA 92128 US
Establishment Type
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Vivachek Biotech (Hangzhou) Co., Ltd
VivaChek Blood Glucose And B-Ketone Monitoring System2020-06-05
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaDiag COVID-19 IgM/IgG Rapid Test2020-04-03
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Via Talk Plus Blood Glucose Monitoring System2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Via Talk Plus Blood Glucose Meter2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Via Talk Deluxe Blood Glucose Monitoring System2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Via Talk Deluxe Blood Glucose Meter2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Via Talk Blood Glucose Monitoring System2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Via Talk Blood Glucose Meter2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Via Sync Blood Glucose Monitoring System2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Via Sync Blood Glucose Meter2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Via Smart Blood Glucose Monitoring System2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Via Smart Blood Glucose Meter2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Via Send Blood Glucose Monitoring System2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Via Send Blood Glucose Meter2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Ino Talk Deluxe Blood Glucose Monitoring system2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Ino Talk Deluxe Blood Glucose Meter2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Ino Talk Blood Glucose Monitoring system2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Ino Talk Blood Glucose Meter2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Ino Smart Blood Glucose Monitoring system2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Ino Smart Blood Glucose Meter2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaChek Ino Sync Blood Glucose Monitoring System2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaChek Ino Sync Blood Glucose Meter2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaChek Ino Sound Simple Blood Glucose Monitoring System2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaChek Ino Sound Simple Blood Glucose Meter2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaChek Ino Sound Bright Blood Glucose Monitoring System2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaChek Ino Sound Bright Blood Glucose Meter2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaChek Ino Sound Blood Glucose Monitoring System2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaChek Ino Sound Blood Glucose Meter2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaChek Ino Smart Blood Glucose Monitoring System2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaChek Ino Smart Blood Glucose Meter2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaChek Ino Plus Blood Glucose Monitoring System2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaChek Ino Plus Blood Glucose Meter2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
FIGGERS HEALTH Smart Blood Glucose Monitoring System2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
FIGGERS HEALTH Smart Blood Glucose Meter2019-02-19
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
Control Solution2017-06-13
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
Blood Glucose Test Strips2017-06-13
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
Blood Glucose Monitoring System2017-06-13
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
Blood Glucose Meter2017-06-13
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Via Control Solution2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Via Blood Glucose Test Strips2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Ino Control Solution2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Ino Blood Glucose Test Strips2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Ino Blood Glucose Monitoring System2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Ino Blood Glucose Meter2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaChek Ino Control Solution2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaChek Ino Blood Glucose Test Strips2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaChek Ino Blood Glucose Monitoring System2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaChek Ino Blood Glucose Meter2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
Healgen Control Solution2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
Healgen Blood Glucose Test Strips2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
Healgen Blood Glucose Monitoring System2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
Healgen Blood Glucose Meter2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
FIGGERS HEALTH Control Solution2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
FIGGERS HEALTH Blood Glucose Test Strips2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
ABOX Control Solution2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
ABOX Blood Glucose Test Strips2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
ABOX Blood Glucose Monitoring System2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
ABOX Blood Glucose Meter2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Via Control Solution2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Via Blood Glucose Test Strips2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Ino Control Solution2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Ino Blood Glucose Test Strips2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Ino Blood Glucose Monitoring System2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Ino Blood Glucose Meter2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaChek Ino Control Solution2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaChek Ino Blood Glucose Test Strips2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaChek Ino Blood Glucose Monitoring System2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaChek Ino Blood Glucose Meter2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
Healgen Control Solution2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
Healgen Blood Glucose Test Strips2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
Healgen Blood Glucose Monitoring System2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
Healgen Blood Glucose Meter2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
FIGGERS HEALTH Control Solution2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
FIGGERS HEALTH Blood Glucose Test Strips2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
ABOX Control Solution2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
ABOX Blood Glucose Test Strips2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
ABOX Blood Glucose Monitoring System2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
ABOX Blood Glucose Meter2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Via Control Solution2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Via Blood Glucose Test Strips2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Ino Control Solution2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Ino Blood Glucose Test Strips2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Ino Blood Glucose Monitoring System2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaGuard Ino Blood Glucose Meter2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaChek Ino Control Solution2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaChek Ino Blood Glucose Test Strips2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaChek Ino Blood Glucose Monitoring System2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
VivaChek Ino Blood Glucose Meter2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
Healgen Control Solution2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
Healgen Blood Glucose Test Strips2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
Healgen Blood Glucose Monitoring System2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
Healgen Blood Glucose Meter2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
FIGGERS HEALTH Control Solution2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
FIGGERS HEALTH Blood Glucose Test Strips2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
ABOX Control Solution2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
ABOX Blood Glucose Test Strips2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
ABOX Blood Glucose Monitoring System2017-05-23
Lee Mariano [VivaChek Biotech (Hangzhou) Co., Ltd]
ABOX Blood Glucose Meter2017-05-23

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