Kyou Hee Lee

FDA Filings

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

FDA Registration(s)
Registration Number3013735968
FEI Number3013735968
NameKyou Hee Lee
Owner & OperatorSmilelab Co., Ltd.
Contact Address464 Dunchon-daero, Suite 1004, Jungwon-g
Seongnam-si KR-41 Gyeonggido 13229 KR
Official Correspondent
  • Kyou H Lee
  • 82-70-42845777-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address627 6th St
Lake Oswego, OR 97034 US
Establishment TypeExport Device to the United States But Perform No Other Operation on Device



FDA Filings

Device
Company
DeviceDate
Kyou Hee Lee [Smilelab Co., Ltd.]
Smilereader ovulation test kit (pregnancy test)2019-04-09
Kyou Hee Lee [Smilelab Co., Ltd.]
PREGABLE ovulation test kit (pregnancy test)2019-04-09
Kyou Hee Lee [Smilelab Co., Ltd.]
Smilereader ovulation test kit (pregnancy test)2019-04-09
Kyou Hee Lee [Smilelab Co., Ltd.]
PREGABLE ovulation test kit (pregnancy test)2019-04-09
Kyou Hee Lee [Smilelab Co., Ltd.]
Smilereader ovulation test kit (pregnancy test)2017-07-20
Kyou Hee Lee [Smilelab Co., Ltd.]
Smilereader ovulation test kit (ovulation test)2017-07-20
Kyou Hee Lee [Smilelab Co., Ltd.]
PREGABLE ovulation test kit (ovulation test)2017-07-20

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