Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009491259

FEI Number

3009491259

Entity Name

BODITECH MED INC.

City/State/Country

Chuncheon Gangwon, KR

Establishment Address

43, Geodudanji 1-gil, Dongnae-myeon, Chuncheon Gangwon 24398, KR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Boditech Med Inc. (Owner Number: 10046783)

Owner / Operator Contact Address

43, Geodudanji 1-gil, Dongnae-myeon, Chuncheon, KR-42 24398, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AFIAS Estradiol AFIAS LH AFIAS FSH AFIAS Insulin OneStep + Pro Hb Microcuvettes OneStep + Pro Hb Analyzer OneStep + Pro Hb Control OneStep + Pro Hb Analyzer Starter Kit hemochroma PLUS Analyzer hemochroma PLUS Analyzer Promo Kit hemochroma PLUS Control hemochroma PLUS Optical System Check hemochroma PLUS Microcuvettes OneStep + Pro Hb Optical System Check Boditech Hormone Control AFIAS C-peptide AFIAS-6 AFIAS-1 AFIAS-10 ichroma-50 PLUS AFIAS-3 AFIAS PRL i-CHROMA iFOB Controls

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CHP	Radioimmunoassay, Estradiol	Clinical Chemistry	Class 1	862.1260	2026-02-05
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2023-06-12
CGJ	Radioimmunoassay, Follicle-Stimulating Hormone	Clinical Chemistry	Class 1	862.1300	2023-06-12
CFP	Radioimmunoassay, Immunoreactive Insulin	Clinical Chemistry	Class 1	862.1405	2025-03-04
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2018-11-28
GGM	Control, Hemoglobin	Hematology	Class 2	864.8625	2018-11-28
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2023-08-20
JKD	Radioimmunoassay, C-Peptides Of Proinsulin	Clinical Chemistry	Class 1	862.1135	2026-06-01
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	Class 1	862.2560	2021-12-03
CFT	Radioimmunoassay, Prolactin (Lactogen)	Clinical Chemistry	Class 1	862.1625	2023-06-12
OOX	Automated Occult Blood Analyzer	Hematology	Class 2	864.6550	2014-05-12
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-05-12

Official Correspondent

Young Min Kim

US Agent Details

Jung Hee Kim Business: Immunostics Inc. Email: jhkim@immunostics.com Phone: (732) 9180770

Related Public Records

Same Entity

Boditech Med Inc.

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
K833852	Syncor Intl. Corp.	FSH RIA	1984-01-13
K990531	Ortho-Clinical Diagnostics, Inc.	VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS	1999-03-12
K982637	Diagnostic Products Corp.	IMMULITE PSA CONTROL MODULE, MODEL LPSCM	1998-08-12
K012468	Dade Behring, Inc.	MODIFICATION TO N/T PROTEIN CONTROL SL	2001-09-04
K971921	Monobind	PROLACTIN (PRL) HORMONE MICROPLATE ELISA	1997-06-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

Similar Registrations

Registration Number	Establishment Name	Location
2122870	BECKMAN COULTER, INC.	CHASKA, MN, US
2432235	Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, US
3003741796	DIRUI INDUSTRIAL CO., LTD.	CHANGCHUN Jilin, CN
3009335633	DiaSource ImmunoAssays, SA	Louvain-La-Neuve Brabant Wallon, BE
8020888	Siemens Healthcare Diagnostics Manufacturing Ltd.	SWORDS Dublin, IE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009491259. Last updated year: 2026. Please use registration number 3009491259 when referencing this establishment in official correspondence.