FDA Registration
Active
🇰🇷 South Korea
SD BIOSENSOR, INC.
Reg #: 3012133212
·
FEI: 3012133212
·
Expires 2026
Products
7
Proprietary Names
16
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- SD BIOSENSOR, INC.
- Registration Number
- 3012133212
- FEI Number
- 3012133212
- Status
- Active
- Expiry Year
- 2026
- 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
- K100398
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
- 2552 Walnut Ave Ste 230
- City
- Tustin
- State
- CA
- ZIP
- 92780
- Country
- US
- [email protected]
- Phone
- 714 9225276
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2020-04-13 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2024-07-24 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2011-03-23 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2011-03-23 |
| 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 |
| Ldl & Vldl Precipitation, Hdl | LBR | Class 1 | Clinical Chemistry | No | 2017-12-04 |
Proprietary Names
Pilot COVID-19 At-Home Test
STANDARD COVID-19 Ag Control Swab
STANDARD Q COVID-19 Ag Test 2
STANDARD LipidoCare Control
STANDARD GlucoNavii
SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM
SD CodeFree
Catalogue Number 01GC11 Series
STANDARD LipidoCare BT Professional System
STANDARD LipidoCare Professional System
STANDARD LipidoCare BT Home System
STANDARD LipidoCare Home System
CURO L7 System
STANDARD LipidoCare Blood Glucose Test Strip
STANDARD LipidoCare Home System
STANDARD LipidoCare Lipid Profile Lipid Test Strip Lipid Profile
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility