FDA applicant

Wholepower Biotech Co., Ltd.

Guangzhou, CN1 decision2019–20190 recalls

FDA records 1 decision for Wholepower Biotech Co., Ltd. (Guangzhou, CN) in 2019: 1 510(k) clearance. All are in product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). 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 Wholepower Biotech Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Wholepower Biotech Co., Ltd. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Wholepower Biotech Co., Ltd.

Which product codes does it file in?

What has FDA decided for it lately?