Core Technology Co L T D

FDA Filings

This page includes the latest FDA filings for Core Technology 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 Number3008054239
FEI Number3008054239
NameCORE TECHNOLOGY CO., LTD.
Owner & OperatorCore Technology Co., Ltd.
Contact AddressRoom 100, Building C, No.29 Life Park Road, Changping District
Beijing City CN-11 Beijing 102206 CN
Official Correspondent
  • Chen Lizhu
  • 86-10-69390616-x
US Agent
Importing Logistics Registration
ImporterCoretests, Inc
Address6190 Yarrow Dr
Carlsbad, CA 92011 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressRoom 100, Building C, No.29 Life Park Road, Changping District
Beijing City Beijing, 102206 CN
Establishment Type
  • Export Device to the United States But Perform No Other Operation on Device
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Core Technology Co.,Ltd.
Genabio 2022-09-20
CORE TECHNOLOGY CO., LTD.
COVID-19 IgM/IgG Ab Test2020-03-31
CORE TECHNOLOGY CO., LTD.
ACCU NEWS Single Drug Screen Test, THC Test2016-08-12
CORE TECHNOLOGY CO., LTD.
ACCU NEWS Single Drug Screen Test, COC Test2016-08-12
CORE TECHNOLOGY CO., LTD.
ACCU NEWS Multi-Drug Screen Test, Multi-Drug 5 Test Panel (THC-COC-MET-AMP-MOP)2016-08-12
CORE TECHNOLOGY CO., LTD.
ACCU NEWS Drug Test Cup, Multi Drug 5 Urine Cup (THC-COC-MET-AMP-MOP)2016-08-12
CORE TECHNOLOGY CO., LTD.
ACCU NEWS Single Drug Screen Test, THC Test2016-08-12
CORE TECHNOLOGY CO., LTD.
ACCU NEWS Single Drug Screen Test, COC Test2016-08-12
CORE TECHNOLOGY CO., LTD.
ACCU NEWS Multi-Drug Screen Test, Multi-Drug 5 Test Panel (THC-COC-MET-AMP-MOP)2016-08-12
CORE TECHNOLOGY CO., LTD.
ACCU NEWS Drug Test Cup, Multi Drug 5 Urine Cup (THC-COC-MET-AMP-MOP)2016-08-12
CORE TECHNOLOGY CO., LTD.
ACCU NEWS Single Drug Screen Test, THC Test2016-08-12
CORE TECHNOLOGY CO., LTD.
ACCU NEWS Single Drug Screen Test, COC Test2016-08-12
CORE TECHNOLOGY CO., LTD.
ACCU NEWS Multi-Drug Screen Test, Multi-Drug 5 Test Panel (THC-COC-MET-AMP-MOP)2016-08-12
CORE TECHNOLOGY CO., LTD.
ACCU NEWS Drug Test Cup, Multi Drug 5 Urine Cup (THC-COC-MET-AMP-MOP)2016-08-12
CORE TECHNOLOGY CO., LTD.
ACCU NEWS Single Drug Screen Test, THC Test2016-08-12
CORE TECHNOLOGY CO., LTD.
ACCU NEWS Single Drug Screen Test, COC Test2016-08-12
CORE TECHNOLOGY CO., LTD.
ACCU NEWS Multi-Drug Screen Test, Multi-Drug 5 Test Panel (THC-COC-MET-AMP-MOP)2016-08-12
CORE TECHNOLOGY CO., LTD.
ACCU NEWS Drug Test Cup, Multi Drug 5 Urine Cup (THC-COC-MET-AMP-MOP)2016-08-12
CORE TECHNOLOGY CO., LTD.
ACCU NEWS Single Drug Screen Test, THC Test2016-08-12
CORE TECHNOLOGY CO., LTD.
ACCU NEWS Single Drug Screen Test, COC Test2016-08-12
CORE TECHNOLOGY CO., LTD.
ACCU NEWS Multi-Drug Screen Test, Multi-Drug 5 Test Panel (THC-COC-MET-AMP-MOP)2016-08-12
CORE TECHNOLOGY CO., LTD.
ACCU NEWS Drug Test Cup, Multi Drug 5 Urine Cup (THC-COC-MET-AMP-MOP)2016-08-12
CORE TECHNOLOGY CO., LTD.
Veltest HCG pregnancy test2016-01-18
CORE TECHNOLOGY CO., LTD.
Unitest HCG pregnancy test2016-01-18
CORE TECHNOLOGY CO., LTD.
Unitest HCG pregnancy test strip2016-01-18
CORE TECHNOLOGY CO., LTD.
Unitest HCG pregnancy test midstream2016-01-18
CORE TECHNOLOGY CO., LTD.
Freedom urine HCG pregnancy test strip2016-01-18
CORE TECHNOLOGY CO., LTD.
Freedom urine HCG pregnancy test midstream2016-01-18
CORE TECHNOLOGY CO., LTD.
Freedom HCG pregnancy test2016-01-18
CORE TECHNOLOGY CO., LTD.
Femometer Ovulation & Pregnancy Test Combo2016-01-18
CORE TECHNOLOGY CO., LTD.
Babycheck HCG pregnancy test strip2016-01-18
CORE TECHNOLOGY CO., LTD.
Babycheck HCG pregnancy test midstream2016-01-18
CORE TECHNOLOGY CO., LTD.
ACCU NEWS Pregnancy Test Strip2016-01-18
CORE TECHNOLOGY CO., LTD.
ACCU NEWS Pregnancy Test Midstream2016-01-18
CORE TECHNOLOGY CO., LTD.
ACCU NEWS Pregnancy Test Cassette2016-01-18
CORE TECHNOLOGY CO., LTD.
ACCU NEWS Ovulation Test + Pregnancy Test Combo2016-01-18
CORE TECHNOLOGY CO., LTD.
ACCU NEWS One Step hCG Pregnancy Test Strip2016-01-18
CORE TECHNOLOGY CO., LTD.
ACCU NEWS One Step hCG Pregnancy Test Midstream2016-01-18
CORE TECHNOLOGY CO., LTD.
ACCU NEWS One Step hCG Pregnancy Test Cassette2016-01-18
CORE TECHNOLOGY CO., LTD.
Walgreens One Step Ovulation Test2013-04-18
CORE TECHNOLOGY CO., LTD.
Walgreens Daily Ovulation Predictor2013-04-18
CORE TECHNOLOGY CO., LTD.
Veltest LH ovulation test2013-04-18
CORE TECHNOLOGY CO., LTD.
Unitest LH ovulation test2013-04-18
CORE TECHNOLOGY CO., LTD.
Unitest LH ovulation test strip2013-04-18
CORE TECHNOLOGY CO., LTD.
Unitest LH ovulation test midstream2013-04-18
CORE TECHNOLOGY CO., LTD.
OvuCheck Daily Ovulation Test Strip2013-04-18
CORE TECHNOLOGY CO., LTD.
OvuCheck Daily Ovulation Test Midstream2013-04-18
CORE TECHNOLOGY CO., LTD.
Freedom urine LH ovulation test strip2013-04-18
CORE TECHNOLOGY CO., LTD.
Freedom urine LH ovulation test midstream2013-04-18
CORE TECHNOLOGY CO., LTD.
Freedom LH ovulation test2013-04-18
CORE TECHNOLOGY CO., LTD.
Femometer Ovulation Test2013-04-18
CORE TECHNOLOGY CO., LTD.
Coretests Daily Ovulation Test Strip2013-04-18
CORE TECHNOLOGY CO., LTD.
Coretests Daily Ovulation Test Midstream2013-04-18
CORE TECHNOLOGY CO., LTD.
ACCU NEWS Ovulation Test + Pregnancy Test Combo2013-04-18

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020090953902Pusan,South Korea -> Los Angeles, CaliforniaCOVID-19 IGM/IGG AB TEST204 CTN
2019081525884Pusan,South Korea -> Los Angeles, CaliforniaDOOR1 CTN

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