Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029916095

FEI Number

3029916095

Entity Name

Precision Biosensor Inc. 2nd Factory

City/State/Country

Yuseong-gu Daejeon, KR

Establishment Address

310-11, Techno 2-ro, Yuseong-gu Daejeon 34036, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Precision Biosensor Inc. (Owner Number: 10050547)

Owner / Operator Contact Address

306, Techno 2-ro, Yuseong-gu, KR-30 34036, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Fluoro-Checker TRF Nano-Checker 710 Exdia TRF Plus

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	Class 1	862.2560	2018-12-10
JQT	Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica	Clinical Chemistry	Class 1	862.2400	2017-01-19
JZT	Fluorometer	Immunology	Class 1	866.4520	2020-01-19

Official Correspondent

Jihyun Lee

US Agent Details

James Chang Business: Nano-Ditech Corporation Email: jchang@nanoditech.com Phone: (609) 4093300

Related Public Records

Same Entity

Precision Biosensor 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
K915332	Ciba Corning Diagnostics Corp.	MODEL 795 FLUOROMETER/DENSITOMETER	1992-02-18

Similar Registrations

Registration Number	Establishment Name	Location
3004529019	Tosoh Hi-Tec, Inc.	Yamaguchi, JP
3009092698	NANOENTEK INC	Seoul, KR
3012516456	ANZA PACKAGING & DISPLAYS DE MEXICO S. DE R.L. DE C.V.	TIJUANA Baja California, MX
3010381606	EMSERE BV	Leiden Zuid-Holland, NL
3003366417	LRE MEDICAL GMBH	NOERDLINGEN Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029916095. Last updated year: 2026. Please use registration number 3029916095 when referencing this establishment in official correspondence.