Asahi Kasei Pharma Corp

FDA Filings

This page includes the latest FDA filings for Asahi Kasei Pharma Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3003460426
FEI Number3003460426
NameMichael van der Woude
Owner & OperatorAsahi Kasei Pharma Corporation
Contact Address1-1-2 Yurakucho
Chiyoda-ku JP-13 Tokyo 100-0006 JP
Official Correspondent
  • Akitake Yamashita
  • 81-3-66993617-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2500 Bee Cave Rd Bldg 1, Suite 300
Austin, TX 78746 US
Establishment TypeExport Device to the United States But Perform No Other Operation on Device



Registration Number8043889
FEI Number3003206796
NameAsahi Kasei Pharma Corporation, Ohito
Owner & OperatorAsahi Kasei Pharma Corporation
Contact Address1-1-2 Yurakucho
Chiyoda-ku JP-13 Tokyo 100-0006 JP
Official Correspondent
  • Akitake Yamashita
  • 81-3-66993617-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address632-1 Mifuku
Izunokuni City Sizuoka, 410-2321 JP
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
ASAHI KASEI PHARMA CORPORATION
Lucica® Glycated Albumin-L GA R-1 L212GA2019-10-29
ASAHI KASEI PHARMA CORPORATION
Control for Lucica® Glycated Albumin-L G282GA2019-03-11
ASAHI KASEI PHARMA CORPORATION
Calibrator for Lucica® Glycated Albumin-L G252GA2019-03-11
ASAHI KASEI PHARMA CORPORATION
Lucica® Glycated Albumin-L ALB R-2 L242GA2019-03-11
ASAHI KASEI PHARMA CORPORATION
Lucica® Glycated Albumin-L ALB R-1 L232GA2019-03-11
ASAHI KASEI PHARMA CORPORATION
Lucica® Glycated Albumin-L GA R-2 L222GA2019-03-11
ASAHI KASEI PHARMA CORPORATION
Lucica Glycated Albumin-L2017-10-12

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