Data / Medical devices / South Korea / SD Biosensor, Inc.
SD Biosensor, Inc.: FDA-registered device maker in Cheongju-si Chungbuk, South Korea, 2 510(k) clearances
SD Biosensor, Inc. is registered with the FDA (registration 3008959428) in Cheongju-si Chungbuk, South Korea. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 17, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008959428
- Address
- 74, Osongsaengmyeong 4-ro, Osong-eup Heungdeok-gu, Cheongju-si Chungbuk, South Korea, 28161
- Owner or operator
- SD Biosensor, Inc. (10035779)
- Roles
- Manufacturer
- First device listed
- March 23, 2011
- Registered through
- 2026
- Brand names listed
- CURO L7 System, Catalogue Number 01GC11 Series, Pilot COVID-19 At-Home Test, SD CodeFree, SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM, STANDARD COVID-19 Ag Control Swab, STANDARD GlucoNavii, STANDARD LipidoCare BT Home System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Colorimetric Method, Triglycerides | JGY | 1 | Manufacturer | accessdata.fda.gov |
| Coronavirus Antigen Detection Test System. | QKP | N | Manufacturer | accessdata.fda.gov |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | 1 | Manufacturer | accessdata.fda.gov |
| Glucose Oxidase, Glucose | CGA | 2 | Manufacturer | accessdata.fda.gov |
| Ldl & Vldl Precipitation, Hdl | LBR | 1 | Manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Manufacturer | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| October 17, 2017 | K160282 | SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System | NBW | Substantially Equivalent | Sd Biosensor | accessdata.fda.gov |
| June 9, 2010 | K100398 | SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Standard Diagnostics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Coronavirus Antigen Detection Test System.
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Glucose Oxidase, Glucose
- All makers of Colorimetric Method, Triglycerides
- All makers of Enzymatic Esterase--Oxidase, Cholesterol
- All makers of Ldl & Vldl Precipitation, Hdl
Updated October 17, 2017. 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.