Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013500651

FEI Number

3013500651

Entity Name

CELLTRAZONE CO., LTD

City/State/Country

GIMPO-SI Seoul, KR

Establishment Address

1F, 6F, 16, ARAYUK-RO, GOCHON-EUP, GIMPO-SI Seoul 10136, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Celltrazone Co., Ltd (Owner Number: 10053102)

Owner / Operator Contact Address

1F, 6F, 16, ARAYUK-RO, GOCHON-EUP, GIMPO-SI, KR-41 10136, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HURO PATH® Solution (Non-GYN) HURO PATH® Solution (GYN) HURO PATH® Solution (Body Fluid) HURO PATH® Solution (SPUTUM) HURO PATH® Lysis Solution (Hemolics) HURO PATH® Solution (FNA) - BULK HURO PATH® Solution (FNA) HURO PATH® Solution (Diluent) HURO PATH® Solution (Body Fluid) - BULK HURO PATH® Solution (GYN) - BULK HURO PATH® Solution (Urine) HURO PATH® Solution (SPUTUM) - BULK HURO PATH® Solution (Urine) - BULK HURO PATH® Solution (Non-GYN) - BULK HURO PATH® Lysis Solution (Contro-reagent) Microscope slide (Adhesive)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LEA	Preservative, Cytological	Pathology	Class 1	864.4010	2016-11-01
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2016-11-01

Official Correspondent

SUN KI KIM

US Agent Details

Jung Ryun Ahn Business: KMC USA, Inc Email: kmc.usa@kmcerti.com Phone: (646) 3576058

Related Public Records

Same Entity

Celltrazone Co., Ltd

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 3013500651. Last updated year: 2026. Please use registration number 3013500651 when referencing this establishment in official correspondence.