Data / Medical devices / South Korea / OSANG Healthcare CO., LTD.
OSANG Healthcare CO., LTD.: FDA-registered device maker in ANYANG Gyeonggi, South Korea, 9 510(k) clearances
OSANG Healthcare CO., LTD. is registered with the FDA (registration 3004146366) in ANYANG Gyeonggi, South Korea. It lists 14 device types. The FDA files 9 510(k) clearances under its listings, the newest dated May 30, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3004146366
- Address
- 132, Anyangcheondong-ro DONGAN-GU, ANYANG Gyeonggi, South Korea, 14040
- Owner or operator
- OSANG HEALTHCARE CO., LTD. (9056376)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- July 14, 2009
- Registered through
- 2026
- Brand names listed
- BinaxNOW COVID-19/FLU A&B CONTROL SWAB KIT, BinaxNOW COVID-19/Flu A&B, BinaxNOW COVID-19/Flu A&B Combo Self Test, CURO L5, Control AST G3, Disposable Blood Lancet, Easygluco G2, Easytouch Healthpro and more
Devices it lists
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 |
| August 31, 2022 | K221507 | Disposable Blood Lancet | QRK | Substantially Equivalent | SteriLance Medical (Suzhou), Inc. | accessdata.fda.gov |
| August 30, 2022 | K221970 | Lancing device | QRL | Substantially Equivalent | SteriLance Medical (Suzhou), Inc. | accessdata.fda.gov |
| July 13, 2021 | K203562 | Finetest Lite Blood Glucose Monitoring System | NBW | Substantially Equivalent | Osang Healthcare Co. , Ltd. | 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 |
| January 8, 2009 | K081703 | MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS | NBW | Substantially Equivalent | Entra Health Systems, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Over-The-Counter Covid-19 Antigen Test
- 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
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.