Accugene Inc

FDA Filings

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

FDA Registration(s)
Registration Number3013228421
FEI Number3013228421
NameACCUGENE, INC
Owner & OperatorAccuGene, Inc
Contact Address17F (IBS Tower, Songdo-dong) 263, Centra
Yeonsu-gu KR-28 Incheon Gwangyeogsiv 22006 KR
Official Correspondent
  • Jong Yoon Kim
  • 82-32-7103615-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address17F (IBS Tower, Songdo-dong) 263, Central-ro
Yeonsu-gu Incheon Gwangyeogsiv, 22006 KR
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
ACCUGENE, INC
AccuStool Collection Kit Dx2019-04-22
ACCUGENE, INC
AccuSaliva Collection Kit Dx2019-04-22
ACCUGENE, INC
AccuBuccal Collection Kit Dx2019-04-22

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020080755618Pusan,South Korea -> Long Beach, CaliforniaFOOD PREPARATIONS 2106.903 PKG

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