Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016788237

FEI Number

3016788237

Entity Name

GD GROUP CO., LTD.

City/State/Country

Eumseong Chungbuk, KR

Establishment Address

29 Seongbonsandan 6-ro,, Geumwang-eup, Eumseong Chungbuk 27741, KR

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

GANGDONG GROUP CO., LTD. (Owner Number: 10078653)

Owner / Operator Contact Address

29 Seongbonsandan 6-ro, Geumwang-eup, Eumseong, KR-43 27741, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Low Profile Microtome Blades 35L; High Profile Microtome Blades 35H; Trimming Blades Embedding Cassette; Biopsy Cassette; Tissue Cassette; Hinged Cassette Ethanol 70%; Ethanol 83%; Ethanol 95%; Ethanol 100%; Isopropyl Alcohol, Xylene; Toluene; Acetone FIXUP®, Fixative Solution PathoLock; 10% Neutral Buffered Formalin Adhesion slides, Non-Adhesion slides, Coverslips OptimalHisto, LumiTreat

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IDL	Microtome, Accessories	Pathology	Class 1	864.3010	2024-02-03
IDZ	Cassettes, Tissue	Pathology	Class 1	864.3010	2020-10-30
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2020-10-30
LDZ	Fixative, Alcohol Containing	Pathology	Class 1	864.4010	2024-02-07
IFP	Formalin, Neutral Buffered	Pathology	Class 1	864.4010	2025-09-21
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2024-02-03

Official Correspondent

SANGHOON KANG

US Agent Details

GREG ROBERTSON Email: fixupbiochem@gmail.com Phone: (425) 3879081

Related Public Records

Same Entity

GANGDONG GROUP CO., LTD.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K761138	Zeus Scientific, Inc.	FA TISSUE FIXATIVE & WASH SET	1978-01-06
K842913	E K Ind., Inc.	WRIGHT STAIN FIXATIVE	1984-09-07

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016788237. Last updated year: 2026. Please use registration number 3016788237 when referencing this establishment in official correspondence.