Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006788232

FEI Number

3006788232

Entity Name

CYTOGEN, INC.

City/State/Country

Seoul, KR

Establishment Address

A-8F, SK V1 GL Metrocity, 128, Beobwon-ro, Songpa-gu, Seoul 05854, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CYTOGEN, Inc. (Owner Number: 10051266)

Owner / Operator Contact Address

B-4F(unit 3,4), 60, Gwacheon-daero 7na-gil, Gwacheon-si, KR-41 13840, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Smart Biopsy IF Stainer Smart Biopsy IF Stainer - CST030 SmartBiopsy Isolation Kit Smart Biopsy Cell Isolator - CIS030 Cell Isolator V2 - CIS060

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2016-07-11
GKH	Apparatus, Automated Blood Cell Diluting	Hematology	Class 1	864.5240	2016-02-24

Official Correspondent

Ji Hoon Ahn

US Agent Details

Ki Eun Kim Business: ExperTox, Inc. Email: kekim@expertox.com Phone: (281) 4764600

Related Public Records

Same Entity

CYTOGEN, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006788232. Last updated year: 2026. Please use registration number 3006788232 when referencing this establishment in official correspondence.