FDA Registration
Active
🇰🇷 South Korea
STANDARD LipidoCare Home System
Reg #: 3012133212
·
FEI: 3012133212
·
Expires 2025
Products
4
Proprietary Names
8
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- SD BIOSENSOR, INC.
- Registration Number
- 3012133212
- FEI Number
- 3012133212
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- C-4th&5th, 16, Deogyeong-daero, 1556beon-gil, Yeongtong-gu
- City
- Suwon-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K160282
Owner / Operator
- Firm Name
- SD Biosensor, Inc.
- Operator Number
- 10035779
- Address
- C-4th&5th, 16, Deogyeong-daero, 1556beon-gil, Yeongtong-gu
- City
- Suwon-si
- State
- Gyeonggi
- Postal Code
- 16690
- Country
- KR
- Correspondent
- Hyo-Keun Lee
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 |
|---|---|---|---|---|---|
| Colorimetric Method, Triglycerides | JGY | Class 1 | Clinical Chemistry | No | 2017-12-04 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2017-12-04 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2017-12-04 |
| Ldl & Vldl Precipitation, Hdl | LBR | Class 1 | Clinical Chemistry | No | 2017-12-04 |
Proprietary Names
STANDARD LipidoCare Home System
STANDARD LipidoCare BT Home System
STANDARD LipidoCare BT Professional System
STANDARD LipidoCare Professional System
CURO L7 System
STANDARD LipidoCare Home System
STANDARD LipidoCare Blood Glucose Test Strip
STANDARD LipidoCare Lipid Profile Lipid Test Strip Lipid Profile
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility