FDA Registration Active 🇰🇷 South Korea

Yodoc 10

Reg #: 3005841640 · FEI: 3005841640 · Expires 2025
Products
10
Proprietary Names
3
Establishment Types
1
Classifications
10

Registration Details

Registration Name
DFI CO., LTD.
Registration Number
3005841640
FEI Number
3005841640
Status
Active
Expiry Year
2025
Initial Importer
No
Address
388-25, Gomo-Ro, Jilye-Myeon,
City
Gimhae-Si Gyeongnam
Country
KR

Regulatory Submissions

510(k) Number
K052525

Owner / Operator

Firm Name
DFI CO., LTD.
Operator Number
9089171
Address
388-25, Gomo-Ro, Jillye-Myeon,, --
City
Gimhae-Si
State
Chungnam
Postal Code
621-881
Country
KR

US Agent

Business Name
LK Consulting Group USA, Inc.
Contact Name
Priscilla Chung
Address
18881 Von Karman Ave STE 160
City
Irvine
State
CA
ZIP
92612
Country
US
Phone
714 2025789

Products

Device Name Product Code
Test, Urine Leukocyte LJX
Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) JMA
Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
Blood, Occult, Colorimetric, In Urine JIO
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT

Proprietary Names

Yodoc 10 QTEST™ 11 CYBOW 10

Establishment Types

Manufacture Medical Device