FDA Registration
Active
🇺🇸 United States
OSANG LLC
Reg #: 3020885868
·
FEI: 3020885868
·
Expires 2026
Products
9
Proprietary Names
16
Establishment Types
4
Classifications
9
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Registration Details
- Registration Name
- OSANG LLC
- Registration Number
- 3020885868
- FEI Number
- 3020885868
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 625 Fair Oaks Ave Ste 360
- City
- S Pasadena
- State
- CA
- ZIP
- 91030
- Country
- US
Regulatory Submissions
- 510(k) Number
- K113192
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2013-06-26 |
| 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 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2013-06-26 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2013-06-26 |
| Colorimetric Method, Triglycerides | JGY | Class 1 | Clinical Chemistry | No | 2013-06-26 |
| Glucose Dehydrogenase, Glucose | LFR | Class 2 | Clinical Chemistry | No | 2012-09-13 |
| Over-The-Counter Covid-19 Antigen Test | QYT | Class 2 | Microbiology | No | 2025-06-09 |
| Multi-Analyte Respiratory Virus Antigen Detection Test | SCA | Class 2 | Microbiology | No | 2025-01-14 |
Proprietary Names
CURO L5
G5 Infinity
Easytouch Healthpro
Kroger® Healthpro
OHC COVID-19 Antigen Self Test
Oh'Care Lite
Control AST G3
Member Mark BluLink
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
OKRA Pro
OKRA REFILL KIT
OKRA Test Strip
Easygluco G2
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility