510(k) Report

FDA applicant

Delbio Incorporation

Taoyuan County, TW7 decisions2011–20140 recalls

FDA records 7 decisions for Delbio Incorporation (Taoyuan County, TW) from 2011 to 2014: 7 510(k) clearances. Most are in product codes NBW (System, Test, Blood Glucose, Over The Counter) and DQA (Oximeter). 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 Delbio Incorporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2011: 12012: 32013: 22014: 1
2011high 3 (2012) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Delbio Incorporation by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Delbio”

FDA records each applicant name separately; these may or may not be the same firm.