510(k) Report

FDA applicant

DFI Co., Ltd.

Gyeongsangnam-Do, KR4 decisions2006–20180 recalls

FDA records 4 decisions for DFI Co., Ltd. (Gyeongsangnam-Do, KR) from 2006 to 2018: 4 510(k) clearances. Most are in product codes JIL (Method, Enzymatic, Glucose (Urinary…) and KQO (Automated Urinalysis System). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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 DFI Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2018

2011: 12018: 2
2007high 2 (2018) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)3decisions
  • 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:

What has FDA decided for it lately?

  • K181024DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent StripsDFI Co., Ltd. · 2018
  • K171521DUS R-50S (Urine Chemistry system)DFI Co., Ltd. · 2018
  • K102188Cybow Reader, Models 300 & 720DFI Co., Ltd. · 2011
  • K052525Cybow 11 Series Reagent Strips for UrinalysisDFI Co., Ltd. · 2006

All 4 as DFI Co., Ltd. →