510(k) Report

FDA applicant

Shanghai Venture Bio-Tech Co., Ltd.

Shanghai, CN2 decisions2018–20180 recalls

FDA records 2 decisions for Shanghai Venture Bio-Tech Co., Ltd. (Shanghai, CN) in 2018: 2 510(k) clearances. Most are in product codes DKZ (Enzyme Immunoassay, Amphetamine) and DJC (Thin Layer Chromatography, Methamphetamine). Its devices cite 2 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 toxicology panel, where it files most

How often FDA has decided Shanghai Venture Bio-Tech Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2018

2018: 2
2018high 2 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Shanghai Venture Bio-Tech Co., Ltd. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DKZEnzyme Immunoassay, Amphetamine1decision
  • DJCThin Layer Chromatography, Methamphetamine1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K180878BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC…Shanghai Venture Bio-Tech Co., Ltd. · 2018
  • K180879BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for…Shanghai Venture Bio-Tech Co., Ltd. · 2018

All 2 as Shanghai Venture Bio-Tech Co., Ltd. →