Kate Twomey

FDA Filings

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

FDA Registration(s)
Registration Number3013160357
FEI Number3013160357
NameKate Twomey
Owner & OperatorRR Donnelley Global Turnkey Solutions
Contact Address6315 W BY NORTHWEST BLVD
Houston TX 77040 US
Official Correspondent
  • KATE TWOMEY
  • 1-713-3541397-1397
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address6315 West by Northwest Blvd Houston
Houston, TX 77040 US
Establishment TypeRepack or Relabel Medical Device



Registration Number3006534878
FEI Number3006534878
NameKate Twomey
Owner & OperatorRR Donnelley - Global Turnkey Solutions
Contact Address30 Toh Guan Road #05-01
Singapore SG-NOTA 608840 SG
Official Correspondent
  • Kelvin Wong
  • 065-6672-7881-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address6315 West by Northwest Blvd Houston
Houston, TX 77040 US
Establishment Type
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Export Device to the United States But Perform No Other Operation on Device



FDA Filings

Device
Company
DeviceDate
Kate Twomey [RR Donnelley Global Turnkey Solutions]
Bio Bag2018-07-19
Kate Twomey [RR Donnelley Global Turnkey Solutions]
Droppers2018-07-19
Kate Twomey [RR Donnelley Global Turnkey Solutions]
Ninhydrin, Nitrate A and B, Oxidase, PRY, Voges Proskauer A and B2018-07-19
Kate Twomey [RR Donnelley Global Turnkey Solutions]
Dropper reagents - 10% KOH, 10% Na Desosycholate, Catalase, DMACA Indole, FeCI(3), Indole, Methylene Blue Loeffler,2018-07-19
Kate Twomey [RR Donnelley Global Turnkey Solutions]
Droppers2018-07-19
Kate Twomey [RR Donnelley Global Turnkey Solutions]
Clay Adams2018-07-19
Kate Twomey [RR Donnelley Global Turnkey Solutions]
Affirm? VPIII Ambient Temperature Transfer System2018-07-11
Kate Twomey [RR Donnelley - Global Turnkey Solutions]
Freestyle2012-10-24
Kate Twomey [RR Donnelley - Global Turnkey Solutions]
Freestyle2012-10-24
Kate Twomey [RR Donnelley - Global Turnkey Solutions]
Xceed2012-10-24
Kate Twomey [RR Donnelley - Global Turnkey Solutions]
Xceed2012-10-24
Kate Twomey [RR Donnelley - Global Turnkey Solutions]
InsuLinx2012-09-26
Kate Twomey [RR Donnelley - Global Turnkey Solutions]
InsuLinx2012-09-26
Kate Twomey [RR Donnelley - Global Turnkey Solutions]
Xceed H2012-09-26
Kate Twomey [RR Donnelley - Global Turnkey Solutions]
Xceed H2012-09-26

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