YD Diagnostics
Yongin-si Gyeonggi, KR
YD DIAGNOSTICS appears in FDA device records in Yongin-si Gyeonggi, KR. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for YD Diagnostics between 2002 and 2018. The busiest year on record is 2002, with 1. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2015 | 1 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K182038 | URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer | JFY | Substantially Equivalent | |
| K141874 | URISCAN OPTIMA | KQO | Substantially Equivalent | |
| K060953 | OCCULTECH FECAL OCCULT BLOOD RAPID TEST | KHE | Substantially Equivalent | |
| K050801 | URISCAN OPTIMA II URINE ANALYZER | JIL | Substantially Equivalent | |
| K023027 | PREG-Q EARLY PREGNANCY TEST | LCX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9710094 | 3003347234 | YD DIAGNOSTICS | 76, Seori-ro, Idong-eup, Cheoin-gu, Yongin-si Gyeonggi 17127 KR | 2026 | and 9 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
- KQOAutomated Urinalysis System
- JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
- JIOBlood, Occult, Colorimetric, In Urine
- JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- JFYEnzymatic Method, Creatinine
- LDZFixative, Alcohol Containing
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
- JINNitroprusside, Ketones (Urinary, Non-Quant.)
- LEAPreservative, Cytological
- KHEReagent, Occult Blood
- JRERefractometer For Clinical Use
- KEWSlides, Microscope
- LJXTest, Urine Leukocyte
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain