Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710094

FEI Number

3003347234

Entity Name

YD DIAGNOSTICS

City/State/Country

Yongin-si Gyeonggi, KR

Establishment Address

76, Seori-ro, Idong-eup, Cheoin-gu, Yongin-si Gyeonggi 17127, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

YD DIAGNOSTICS (Owner Number: 9044716)

Owner / Operator Contact Address

76, Seori-ro, Idong-myeon, Cheoin-gu, Yongin-si, KR-41 17127, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EASYPREP Preservative Solution Occultech FOB Test Uriscan S-300 EASYPREP SLIDE GLASS Uriscan Optima + Uriscan 2ACR Strip Uriscan Optima + Uriscan Multiple parameter strips Uriscan Urine Test Strips PREG-Q Pregnancy Test EASYPREP FIXATIVE SOLUTION

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LEA	Preservative, Cytological	Pathology	Class 1	864.4010	2016-01-21
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2007-12-18
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2020-03-03
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2020-03-03
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2020-03-03
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2017-12-17
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2015-12-07
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2015-12-07
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2015-12-07
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2007-12-18
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2007-12-18
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2007-12-18
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2007-12-18
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2007-12-18
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2007-12-18
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2007-12-18
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2007-12-18
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2007-12-18
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2007-12-18
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2007-12-18
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2007-12-18
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2007-12-18
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2007-12-18
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2007-12-18
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2007-12-18
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2007-12-18
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2007-12-18
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2007-12-18
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2007-12-18
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	Clinical Chemistry	Class 1	862.1095	2007-12-18
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2007-12-18
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2007-12-18
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2007-12-18
LDZ	Fixative, Alcohol Containing	Pathology	Class 1	864.4010	2016-01-21

Official Correspondent

No official correspondent registered.

US Agent Details

JERRI PIH (HOI) JERRI HOI Business: BIOSYS LABORATORIES, INC. Email: hoi@biosyslabs.com Phone: (626) 4036565

Related Public Records

Same Entity

YD DIAGNOSTICS

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
K162333	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo One Step Fecal Occult Blood (FOB) Test	2017-05-14
K101852	Iris International Inc., A Division of Iris Iris I	CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT	2011-03-23
K885053	Biotrol, USA, Inc.	BIOTROL URINE PROTEINS REAGENT	1989-01-30
K012065	Wiener Laboratories Saic	WIENER LAB. CREATININA CINETICA AA	2001-10-10
K183555	Instrumentation Laboratory CO	GEM Premier ChemSTAT	2019-02-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0081-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine analyzer.
Z-0082-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status Connect System The Clinitek Status system is a urine analyzer.
Z-0083-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part The Clinitek Status system is a urine analyzer.
Z-0008-2009	Roche Diagnostics Corp.	2	Roche Diagnostics CREP2, Creatinine Plus Ver. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03263991190. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of creatine in serum, urine and plasma.
Z-0006-05	Abbott Health Products, Inc.	2	AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21

Similar Registrations

Registration Number	Establishment Name	Location
3009034535	CELLSOLUTIONS LLC	Greensboro, NC, US
3011496777	BIODYNE	Seoul, KR
1419341	Leica Biosystems Richmond, Inc.	Richmond, IL, US
1221855	Hologic, Inc.	LONDONDERRY, NH, US
3006330030	Hologic, Inc.	Marlborough, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710094. Last updated year: 2026. Please use registration number 9710094 when referencing this establishment in official correspondence.