FDA Registration
Active
🇰🇷 South Korea
CYBOW Reader 720
Reg #: 3005841640
·
FEI: 3005841640
·
Expires 2025
Products
12
Proprietary Names
6
Establishment Types
1
Classifications
12
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
- K102188
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
- [email protected]
- Phone
- 714 2025789
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2011-09-22 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2011-09-22 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2011-09-22 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2011-09-22 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2011-09-22 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2011-09-22 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2011-09-22 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2011-09-22 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2011-09-22 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2011-09-22 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2011-09-22 |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | Class 1 | Clinical Chemistry | No | 2011-09-22 |
Proprietary Names
CYBOW Reader 720
CYBOW 11
CYBOW 10
CYBOW Reader 300
ComboStik 10M
ComboStik R-300
Establishment Types
Manufacture Medical Device