Sanae Kartchner

FDA Filings

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

FDA Registration(s)
Registration Number3005748564
FEI Number3005748564
NameSanae Kartchner
Owner & OperatorPRECISION SYSTEM SCIENCE COMPANY LIMITED
Contact Address88 Kamihongou
Matsudo-city, Chiba-Pref. JP-12 Tiba 271-0064 JP
US Agent
Importing Logistics Registration
ImporterPRECISION SYSTEM SCIENCE COMPANY LIMITED
Address88 kamihongou
matsudo-city, 271-0064 JAPAN
Importer TypeAgent
SubdivisionJP-12
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address5673 W. Las Positas Blvd., Suite 202
Pleasanton, CA 94588 US
Establishment Type
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Develop Specifications But Do Not Manufacture At This Facility



Registration Number3000287971
FEI Number3000287971
NameSanae Kartchner
Owner & OperatorFURUKAWA ELECTRIC ADVANCED ENGINEERING CO.,LTD.
Contact Address6,YAWATA-KAIGANDORI
Ichihara JP-12 Tiba 2908555 JP
Official Correspondent
  • KAZUHIRO YOKOYAMA
  • 81-436-421603-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address5673 W. Las Positas Blvd., Suite 202
Pleasanton, CA 94588 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
Sanae Kartchner [FURUKAWA ELECTRIC ADVANCED ENGINEERING CO.,LTD.]
nCounter Prep Station 5s2019-07-07
Sanae Kartchner [FURUKAWA ELECTRIC ADVANCED ENGINEERING CO.,LTD.]
nCounter Prep Station 5s2019-07-07
Sanae Kartchner [PRECISION SYSTEM SCIENCE COMPANY LIMITED]
nCounter Prep Station 5s2016-11-28
Sanae Kartchner [PRECISION SYSTEM SCIENCE COMPANY LIMITED]
nCounter Prep Station 5s2016-11-28
Sanae Kartchner [PRECISION SYSTEM SCIENCE COMPANY LIMITED]
PATHFAST2008-11-19

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