Data / Medical devices / South Korea / SD Biosensor, Inc.
SD Biosensor, Inc.: FDA-registered device maker in Suwon-si Gyeonggi, South Korea, 2 510(k) clearances
SD Biosensor, Inc. is registered with the FDA (registration 3012133212) in Suwon-si Gyeonggi, South Korea. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 17, 2017. 2 recall events name it as the recalling firm (2 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012133212
- Address
- C-4th&5th, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si Gyeonggi, South Korea, 16690
- Owner or operator
- SD Biosensor, Inc. (10035779)
- Roles
- Specification developer
- 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 | Specification developer | accessdata.fda.gov |
| Coronavirus Antigen Detection Test System. | QKP | N | Specification developer | accessdata.fda.gov |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | 1 | Specification developer | accessdata.fda.gov |
| Glucose Oxidase, Glucose | CGA | 2 | Specification developer | accessdata.fda.gov |
| Ldl & Vldl Precipitation, Hdl | LBR | 1 | Specification developer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Specification developer | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | 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 |
|---|---|---|---|---|---|---|
| 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 |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 31, 2023 | 92137 | Class I | Ongoing | Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728) | The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor when the buffer is brought close to the nose. | accessdata.fda.gov |
| January 31, 2022 | 89527 | Class I | Ongoing | STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample. | Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved, cleared or authorized for distribution within the U.S. | accessdata.fda.gov |
Compare with other makers
- All makers of Colorimetric Method, Triglycerides
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Enzymatic Esterase--Oxidase, Cholesterol
- All makers of Ldl & Vldl Precipitation, Hdl
- All makers of Glucose Oxidase, Glucose
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
Updated May 23, 2023. 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.