Data / Medical devices / United States / Osang LLC
Osang LLC: FDA-registered device maker in S Pasadena, CA, United States, 5 510(k) clearances
Osang LLC is registered with the FDA (registration 3020885868) in S Pasadena, CA, United States. It lists 9 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 30, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3020885868
- Address
- 625 Fair Oaks Ave Ste 360, S Pasadena, CA, United States, 91030
- Owner or operator
- OSANG HEALTHCARE CO., LTD. (9056376)
- Roles
- Complaint file establishment, Contract manufacturer, Repackager or relabeler, Specification developer
- First device listed
- July 14, 2009
- Registered through
- 2027
- Brand names listed
- BinaxNOW COVID-19/Flu A&B, BinaxNOW COVID-19/Flu A&B Combo Self Test, CURO L5, Control AST G3, Easygluco G2, Easytouch Healthpro, G5 Infinity, Kroger® Healthpro and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Colorimetric Method, Triglycerides | JGY | 1 | Contract manufacturer | accessdata.fda.gov |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | 1 | Contract manufacturer | accessdata.fda.gov |
| Glucose Dehydrogenase, Glucose | LFR | 2 | Complaint file establishment, Contract manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Glucose Oxidase, Glucose | CGA | 2 | Contract manufacturer | accessdata.fda.gov |
| Ldl & Vldl Precipitation, Hdl | LBR | 1 | Contract manufacturer | accessdata.fda.gov |
| Multi-Analyte Respiratory Virus Antigen Detection Test | SCA | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Over-The-Counter Covid-19 Antigen Test | QYT | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Complaint file establishment, Contract manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Complaint file establishment, Contract manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 30, 2025 | K241313 | OHC COVID-19 Antigen Self Test | QYT | Substantially Equivalent | Osang, LLC | accessdata.fda.gov |
| January 13, 2025 | K243262 | QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test | SCA | Substantially Equivalent | Osang, LLC | accessdata.fda.gov |
| October 16, 2020 | K201396 | Finetest Lite Smart Blood Glucose Monitoring System | NBW | Substantially Equivalent | Osang Healthcare Co. , Ltd. | accessdata.fda.gov |
| September 19, 2018 | K182286 | Oh'Care Lite Smart Blood Glucose Monitoring System | NBW | Substantially Equivalent | Osang Healthcare Co. , Ltd. | accessdata.fda.gov |
| July 13, 2012 | K113192 | HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Infopia Co, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Glucose Dehydrogenase, Glucose
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Glucose Oxidase, Glucose
- All makers of Ldl & Vldl Precipitation, Hdl
- All makers of Enzymatic Esterase--Oxidase, Cholesterol
Updated May 30, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.