510(k) Report

FDA applicant

Runbio Biotech Co.,Ltd

Shantou, CN3 decisions2006–20190 recalls

FDA records 3 decisions for Runbio Biotech Co.,Ltd (Shantou, CN) from 2006 to 2019: 3 510(k) clearances. All are in product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). 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 chemistry panel, where it files most

How often FDA has decided Runbio Biotech Co.,Ltd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2018: 12019: 1
2007high 1 (2018) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Runbio Biotech Co.,Ltd by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LCXKit, Test, Pregnancy, Hcg, Over The Counter3decisions

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?

  • K181551DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One…Runbio Biotech Co.,Ltd · 2019
  • K172627David Home Pregnancy Test Cassette, David Professional Pregnancy Test CassetteRunbio Biotech Co.,Ltd · 2018
  • K053236David Pregnancy Test (Midstream)Runbio Biotech Co.,Ltd · 2006

All 3 as Runbio Biotech Co.,Ltd →