FDA Registration
Active
🇰🇷 South Korea
OSANG Healthcare CO., LTD.
Reg #: 3004146366
·
FEI: 3004146366
·
Expires 2026
Products
14
Proprietary Names
24
Establishment Types
4
Classifications
14
Registration Details
- Registration Name
- OSANG Healthcare CO., LTD.
- Registration Number
- 3004146366
- FEI Number
- 3004146366
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 132, Anyangcheondong-ro, DONGAN-GU
- City
- ANYANG Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K203562
Owner / Operator
- Firm Name
- OSANG HEALTHCARE CO., LTD.
- Operator Number
- 9056376
- Address
- 132, Anyangcheondong-ro, Dongan-gu
- City
- Anyang
- State
- Gyeonggi
- Postal Code
- 14040
- Country
- KR
- Correspondent
- Chulhun Kang
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 2025789
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2024-11-07 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2009-07-14 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2009-07-14 |
| Over-The-Counter Covid-19 Antigen Test | QYT | Class 2 | Microbiology | No | 2025-06-09 |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | Class 2 | General, Plastic Surgery | No | 2026-05-26 |
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | Class N | Unknown | No | 2020-04-23 |
| Glucose Dehydrogenase, Glucose | LFR | Class 2 | Clinical Chemistry | No | 2013-12-17 |
| Ldl & Vldl Precipitation, Hdl | LBR | Class 1 | Clinical Chemistry | No | 2013-06-26 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2013-06-26 |
| Colorimetric Method, Triglycerides | JGY | Class 1 | Clinical Chemistry | No | 2013-06-26 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | Class 2 | General, Plastic Surgery | No | 2026-04-02 |
| Multi-Analyte Respiratory Virus Antigen Detection Test | SCA | Class 2 | Microbiology | No | 2025-01-14 |
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2022-12-26 |
| Kit, Direct Antigen, Positive Control | MJZ | Class 1 | Clinical Chemistry | No | 2025-01-15 |
Proprietary Names
Finetest Lite
G5 Infinity
OHC COVID-19 Antigen Self Test
Myglucohealth
LDE4 Lancing Device
GeneFinder COVID-19 Plus RealAmp Kit
Easygluco G2
OKRA Pro
OKRA REFILL KIT
OKRA Test Strip
Control AST G3
Oh'Care Lite
CURO L5
Member Mark BluLink
Disposable Blood Lancet
QuickFinder COVID-19/Flu Antigen Self Test
BinaxNOW COVID-19/Flu A&B
BinaxNOW COVID-19/Flu A&B Combo Self Test
QuickFinder COVID-19/Flu Antigen Pro Test
QuickFinder COVID-19/Flu Antigen Self Test
QuickFinder COVID-19/Flu Antigen Pro Control Swab Kit
BinaxNOW COVID-19/FLU A&B CONTROL SWAB KIT
Easytouch Healthpro
Kroger® Healthpro
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Repack or Relabel Medical Device