510(k) Report

FDA applicant

Yd Diagnostics

Yongin-Si, KR5 decisions2002–20180 recalls

FDA records 5 decisions for Yd Diagnostics (Yongin-Si, KR) from 2002 to 2018: 5 510(k) clearances. Most are in product codes JFY (Enzymatic Method, Creatinine) and LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Yd Diagnostics Corp.”, “Yd Diagnostics Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Yd Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2015: 12018: 1
2007high 1 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Yd Diagnostics by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Yd Diagnostics’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • JFYEnzymatic Method, Creatinine1decision
  • LCXKit, Test, Pregnancy, Hcg, Over The Counter1decision
  • KHEReagent, Occult Blood1decision
  • JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)1decision
  • KQOAutomated Urinalysis System1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K141874Uriscan OptimaYd Diagnostics Corp. · 20151cites it

What has FDA decided for it lately?

  • K182038URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzerYd Diagnostics Corporation · 2018
  • K141874Uriscan OptimaYd Diagnostics Corp. · 2015
  • K060953Occultech Fecal Occult Blood Rapid TestYd Diagnostics Corp. · 2006
  • K050801Uriscan Optima II Urine AnalyzerYd Diagnostics · 2005
  • K023027Preg-Q Early Pregnancy TestYd Diagnostics · 2002

All 2 as Yd Diagnostics →All 2 as Yd Diagnostics Corp. →The one decision as Yd Diagnostics Corporation →