Data / Medical devices / South Korea / Yd Diagnostics
Yd Diagnostics: FDA-registered device maker in Yongin-si Gyeonggi, South Korea, 7 510(k) clearances
Yd Diagnostics is registered with the FDA (registration 9710094) in Yongin-si Gyeonggi, South Korea. It lists 19 device types. The FDA files 7 510(k) clearances under its listings, the newest dated December 10, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9710094
- FEI number
- 3003347234
- Address
- 76, Seori-ro, Idong-eup, Cheoin-gu, Yongin-si Gyeonggi, South Korea, 17127
- Owner or operator
- YD DIAGNOSTICS (9044716)
- Roles
- Manufacturer
- First device listed
- February 12, 2001
- Registered through
- 2026
- Brand names listed
- EASYPREP FIXATIVE SOLUTION, EASYPREP Preservative Solution, EASYPREP SLIDE GLASS, Occultech FOB Test, PREG-Q Pregnancy Test, Uriscan Optima + Uriscan 10ACR Strip, Uriscan Optima + Uriscan 2ACR Strip, Uriscan Optima + Uriscan Multiple parameter strips 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 |
|---|---|---|---|---|---|---|
| December 10, 2018 | K182038 | URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer | JFY | Substantially Equivalent | Yd Diagnostics Corporation | accessdata.fda.gov |
| May 28, 2015 | K141874 | URISCAN OPTIMA | KQO | Substantially Equivalent | Yd Diagnostics Corp. | accessdata.fda.gov |
| September 18, 2006 | K060953 | OCCULTECH FECAL OCCULT BLOOD RAPID TEST | KHE | Substantially Equivalent | Yd Diagnostics Corp. | accessdata.fda.gov |
| April 20, 2005 | K050801 | URISCAN OPTIMA II URINE ANALYZER | JIL | Substantially Equivalent | Yd Diagnostics | accessdata.fda.gov |
| December 16, 2002 | K023027 | PREG-Q EARLY PREGNANCY TEST | LCX | Substantially Equivalent | Yd Diagnostics | accessdata.fda.gov |
| June 10, 1998 | K980047 | URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER | KQO | Substantially Equivalent | Yeongdong Pharmaceutical Corp. | accessdata.fda.gov |
| September 5, 1995 | K952307 | BIOSCAN | JIL | Substantially Equivalent | Biosys Laboratories, Inc. | 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 Nitroprusside, Ketones (Urinary, Non-Quant.)
- All makers of Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- All makers of Test, Urine Leukocyte
- All makers of Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
Updated December 10, 2018. 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.