Gkc Manufacturing Pty L T D

FDA Filings

This page includes the latest FDA filings for Gkc Manufacturing Pty 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 Number: 3011705657
• FEI Number: 3011705657
• Name: Global Kinetics USA Corporation
• Owner & Operator: GKC Manufacturing Pty Ltd
• Contact Address: 10913 Bren Road East ; Hopkins MN 55343 US
• Official Correspondent:
  • Megan Graham
  • 1-651-3599042-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 10913 Bren Rd E ; Hopkins, MN 55343 US

• Registration Number: 3011196543
• FEI Number: 3011196543
• Name: GKC MANUFACTURING PTY LTD
• Owner & Operator: GKC Manufacturing Pty Ltd
• Contact Address: 10913 Bren Road East ; Hopkins MN 55343 US
• Official Correspondent:
  • Megan Graham
  • 1-651-3599042-x
• US Agent:
  • Megan Graham
  • Global Kinetics Corporation
  • 651 3599042
  • megan.graham@globalkineticscorp.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Level 9, 31 Queen Street ; Melbourne Victoria, 3000 AU
• Establishment Type:
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 09359011000327 GKC MANUFACTURING PTY LTD	Personal KinetiGraph (PKG)	2024-02-26
GUDID 09359011000280 GKC MANUFACTURING PTY LTD	Personal KinetiGraph (PKG)	2023-10-31
GUDID 09359011000310 GKC MANUFACTURING PTY LTD	Personal KinetiGraph (PKG)	2023-10-30
GUDID 09359011000303 GKC MANUFACTURING PTY LTD	Personal Kinetigraph (PKG)	2023-10-30
GUDID 09359011000297 GKC MANUFACTURING PTY LTD	Personal KinetiGraph (PKG)	2023-10-30
PMN K211887 GKC Manufacturing Pty Ltd	Personal Kinetigraph (PKG) System Gen 2 Plus	2022-03-11
GUDID 09369998208654 GKC MANUFACTURING PTY LTD	Personal Kinetigraph (PKG)	2019-11-08
GUDID 09369998040162 GKC MANUFACTURING PTY LTD	Personal Kinetigraph (PKG)	2019-11-08
GUDID 09369998000562 GKC MANUFACTURING PTY LTD	Personal Kinetigraph (PKG)	2019-11-08
PMN K161717 | NXQ GKC MANUFACTURING PTY LTD	Personal Kinetigraph System	2016-12-19
PMN K161717 | NXQ GKC MANUFACTURING PTY LTD	PKG	2016-12-19
PMN K161717 | ISD GKC MANUFACTURING PTY LTD	Personal Kinetigraph System	2016-12-19
PMN K161717 | ISD GKC MANUFACTURING PTY LTD	PKG	2016-12-19
PMN K161717 | GYD GKC MANUFACTURING PTY LTD	Personal Kinetigraph System	2016-12-19
PMN K161717 | GYD GKC MANUFACTURING PTY LTD	PKG	2016-12-19
PMN K161717 GKC MANUFACTURING PTY LTD.	Personal Kinetigraph (PKG) System	2016-09-20
PMN K140086 | NXQ GKC MANUFACTURING PTY LTD	Personal KinetiGraph (PKG) System	2014-09-22
PMN K140086 | ISD GKC MANUFACTURING PTY LTD	Personal KinetiGraph (PKG) System	2014-09-22
PMN K140086 | GYD GKC MANUFACTURING PTY LTD	Personal KinetiGraph (PKG) System	2014-09-22
PMN K140086 GKC MANUFACTURING PTY LTD.	PERSONAL KINETIGRAPH (PKG) SYSTEM	2014-08-22