FDA applicant

Bestgen Biotech Corp.

Jung-He, Taipei County, TW6 decisions2008–20120 recalls

FDA records 6 decisions for Bestgen Biotech Corp. (Jung-He, Taipei County, TW) from 2008 to 2012: 6 510(k) clearances. Most are in product codes NBW (System, Test, Blood Glucose, Over The Counter) and CGA (Glucose Oxidase, Glucose). Its devices cite 6 predicates, 4 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 Bestgen Biotech Corp.’s devices, and how often a recall has named them.

FDA decisions per year

4in 2012

2008high 4 (2012) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Bestgen Biotech Corp. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bestgen Biotech Corp.’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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Bestgen Biotech Corp.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?