Data / Medical devices / South Korea / Smilelab Co., Ltd.
Smilelab Co., Ltd.: FDA-registered device maker in Seongnam-si Gyeonggi, South Korea, 1 510(k) clearance
Smilelab Co., Ltd. is registered with the FDA (registration 3013735968) in Seongnam-si Gyeonggi, South Korea. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 7, 2015. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013735968
- Address
- RB-106, 33, Sagimakgol-ro 62beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea, Seongnam-si Gyeonggi, South Korea, 13211
- Owner or operator
- Smilelab Co., Ltd. (10055410)
- Roles
- Complaint file establishment, Contract manufacturer, Contract sterilizer, Exporter to the US, Foreign private label distributor, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer
- First device listed
- July 20, 2017
- Registered through
- 2027
- Brand names listed
- PREGABLE ovulation&pregnancy test kit (PREGABLE PREGNANCY TEST)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Complaint file establishment, Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | 1 | Complaint file establishment, Contract manufacturer, Contract sterilizer, Exporter to the US, Foreign private label distributor, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer | accessdata.fda.gov |
| Visual, Pregnancy Hcg, Prescription Use | JHI | 2 | Complaint file establishment, Exporter to the US, Foreign private label distributor | 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 |
|---|---|---|---|---|---|---|
| August 7, 2015 | K150022 | Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream | LCX | Substantially Equivalent | Guangzhou Wondfo Biotech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Visual, Pregnancy Hcg, Prescription Use
- All makers of Kit, Test, Pregnancy, Hcg, Over The Counter
- All makers of Test, Luteinizing Hormone (Lh), Over The Counter
Updated August 7, 2015. 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.