Koga Isotope L T D

FDA Filings

This page includes the latest FDA filings for Koga Isotope 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: 3002807408
• FEI Number: 3002807408
• Name: KOGA ISOTOPE LTD.
• Owner & Operator: KOGA ISOTOPE LTD.
• Contact Address: 53-6 Jinbo,Koka-cho ; Koka-shi JP-25 Siga 520-3404 JP
• US Agent:
  • Kristi O Smedley
  • Center for Regulatory Services, Inc.
  • 703 5907337
  • 703 5808637
  • Smedley@cfr-services.com
• Importing Logistics Registration:
  • Importer: Fertility Laboratories of Colorado, LLC
  • Address: 10290 Ridge Gate Circle ; Lone Tree, CO 80124 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 53-6 Jinbo,Koka-cho ; Koka-shi Siga, 520-3404 JP
• Establishment Type: Sterilize Medical Device for Another Party (Contract Sterilizer)

FDA Filings

Device Company	Device	Date
PUD KOGA ISOTOPE LTD.	Vitri Plate, Warm Plate	2019-12-09
PMN K162051 | MQK KOGA ISOTOPE LTD.	Cryotec (10 pieces) (Blue)	2019-11-27
PMN K101502 | JKA KOGA ISOTOPE LTD.	BD Vacutainer Rapid Serum Tube	2016-12-13
PMN K091292 | JKA KOGA ISOTOPE LTD.	BD Vacutainer	2016-12-13
PMN K142090 | MQV KOGA ISOTOPE LTD.	ReBOSSIS	2016-02-22
PMN K970370 | FMI KOGA ISOTOPE LTD.	TSK Sterijeckt Disposable Hypodermic Needle	2015-10-19
PMN K051187 | MSF KOGA ISOTOPE LTD.	REXEED SERIES DIALYZERS	2013-07-24
PMN K051187 | KDI KOGA ISOTOPE LTD.	REXEED SERIES DIALYZERS	2013-07-24
FMK KOGA ISOTOPE LTD.	Polyslider	2008-03-23