Cytogen Inc

FDA Filings

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

FDA Registration(s)

• Registration Number: 3006788232
• FEI Number: 3006788232
• Name: CYTOGEN, INC.
• Owner & Operator: CYTOGEN, Inc.
• Contact Address: A-8F, SK V1 GL Metrocity, 128, Beobwon-r Songpa-gu; Seoul KR-11 Seoul Teugbyeolsi 05854 KR
• Official Correspondent:
  • Byung Hee Jeon
  • 82-2-4193688-x
• US Agent:
  • April Lee
  • Withus Group Inc.
  • 909 2749971
  • withus6664@gmail.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: A-8F, SK V1 GL Metrocity, 128, Beobwon-ro Songpa-gu; Seoul Seoul Teugbyeolsi, 05854 KR
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 08800021900028 Cytogen, Inc.	Smart Biopsy™ Isolation Kit	2023-05-23
GUDID 08800021900011 Cytogen, Inc.	Smart Biopsy™ IF Stainer	2023-05-23
GUDID 08800021900035 Cytogen, Inc.	Smart Biopsy™ Cell Isolator	2023-05-16
LDZ CYTOGEN, INC.	Cyto-Prep Kit	2017-02-23
IFB CYTOGEN, INC.	Cyto-Prep	2017-02-23
KPA CYTOGEN, INC.	Smart Biopsy? IF Stainer	2016-07-11
KPA CYTOGEN, INC.	Smart Biopsy? IF Stainer - CST030	2016-07-11
KIY CYTOGEN, INC.	Smart Biopsy? Time Lapse Incubator	2016-07-11
GKH CYTOGEN, INC.	SmartBiopsy? Cell Isolator - CIS020	2016-02-24
GKH CYTOGEN, INC.	SmartBiopayTM Isolation Kit	2016-02-24
GKH CYTOGEN, INC.	Smart Biopsy? Cell Isolator - CIS030	2016-02-24