CHUNGDO PHARM. CO., LTD.

FDA Device Registration & Listing · Chuncheon-si Gangwon, KR · Registration 3007301207

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007301207
FEI Number
3007301207
Entity Name
CHUNGDO PHARM. CO., LTD.
City/State/Country
Chuncheon-si Gangwon, KR
Establishment Address
202 BIO-1, 32 Soyanggang-ro, Chuncheon-si Gangwon 24232, KR
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
Chungdo Pharm. Co., Ltd. (Owner Number: 10043194)
Owner / Operator Contact Address
202 BIO-1, 32 Soyanggang-ro, Chuncheon-si, KR-42 24232, KR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

CHEMVIEW-10 CHEMVIEW-10 Self-Stik Uric Acid CHEMVIEW-10 CHEMVIEW-10 Oxidative Stress Test Self-Stik FR Vita-Check CHEMVIEW-10 Self-Stik 2MC AnyScan 300 AnyScan 720 UA 1001 CHEMVIEW-10 CHEMVIEW-10 CHEMVIEW-10 Self-Stik Ca Self-Stik Uric Acid CHEMVIEW-10

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2013-01-30
JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1115 2013-01-30
KNK Acid, Uric, Uricase (Colorimetric) Clinical Chemistry Class 1 862.1775 2024-03-18
JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative) Clinical Chemistry Class 2 862.1340 2013-01-30
KHE Reagent, Occult Blood Hematology Class 2 864.6550 2013-01-30
CEN Dye-Indicator, Ph (Urinary, Non-Quantitative) Clinical Chemistry Class 1 862.1550 2013-01-30
LPT System, Test, Urinary Methylmalonic Acid Clinical Chemistry Class 2 862.1509 2025-03-26
JMA Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) Clinical Chemistry Class 1 862.1095 2013-01-30
JLA Conversion To Creatinine, Creatine Clinical Chemistry Class 1 862.1210 2025-05-25
KQO Automated Urinalysis System Clinical Chemistry Class 1 862.2900 2013-01-30
JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Clinical Chemistry Class 1 862.1510 2013-01-30
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2013-01-30
CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1785 2013-01-30
JNQ Qualitative Chemical Reactions, Urinary Calculi (Stone) Clinical Chemistry Class 1 862.1780 2024-03-18
LFQ Acid, Uric, Acid Reduction Of Ferric Ion Clinical Chemistry Class 1 862.1775 2024-03-18
JRE Refractometer For Clinical Use Clinical Chemistry Class 1 862.2800 2013-01-30

Official Correspondent

Shon Kim

US Agent Details

Kevin Oh Email: cenobiz@hotmail.com Phone: (732) 2457657

Related Public Records

Same Entity

Chungdo Pharm. 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
K885053 Biotrol, USA, Inc. BIOTROL URINE PROTEINS REAGENT 1989-01-30
K830679 Dow Instruments & Reagents, Inc. URIC ACID COLORIMETRIC DETERMINATION 1983-04-06
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

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.

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3008517993 ZHEJIANG ORIENT GENE BIOTECH Huzhou Zhejiang, CN
3014150341 STS CORPORATION Duluth, GA, US
1417592 MEDLINE INDUSTRIES, LP - Northfield Northfield, IL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007301207. Last updated year: 2026. Please use registration number 3007301207 when referencing this establishment in official correspondence.
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