FDA applicant

Sd Biosensor

Suwon-Si, KR6 decisions2014–20170 recalls

FDA records 6 decisions for Sd Biosensor (Suwon-Si, KR) from 2014 to 2017: 6 510(k) clearances. Most are in product codes NBW (System, Test, Blood Glucose, Over The Counter) and LCP (Assay, Glycosylated Hemoglobin). Its devices cite 9 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Sd Biosensor, Inc.”.

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 Sd Biosensor’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2014high 3 (2015) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Sd Biosensor by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Sd Biosensor

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?