Oem Systems Co L T D

FDA Filings

This page includes the latest FDA filings for Oem Systems 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 Number1000487132
FEI Number1000487132
NameKenneth Block
Owner & OperatorOEM SYSTEMS CO. LTD.
Contact Address84 MEKAWA MAKISHIMA-CHO
UJI-SHI KYOTO JP-NOTA 6110041 JP
Official Correspondent
  • Kenneth Block
  • 81-774-202481-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address800 E Campbell Rd Suite 202
Richardson, TX 75081 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
Kenneth Block [OEM SYSTEMS CO. LTD.]
T-TAS 01 Total Thrombus Formation Analysis System Instrument2020-03-16
Kenneth Block [OEM SYSTEMS CO. LTD.]
VARIANTnbs Newborn Screening System2016-02-05
Kenneth Block [OEM SYSTEMS CO. LTD.]
VARIANT II TURBO Link2016-02-05
Kenneth Block [OEM SYSTEMS CO. LTD.]
VARIANT II Hemoglobin Testing System2016-02-05
Kenneth Block [OEM SYSTEMS CO. LTD.]
iMark Microplate Reader2010-02-24

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