510(k) Report

FDA applicant

Ng Biotech

Guipry, FR2 decisions2019–20250 recalls

FDA records 2 decisions for Ng Biotech (Guipry, FR) from 2019 to 2025: 2 510(k) clearances. All are in product code PTJ (Phenotypic Test Kit, Non-Susceptible/Elevated…). Its devices cite 2 predicates, 1 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, microbiology panel, where it files most

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

FDA decisions per year

1in 2025

2019: 12025: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

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

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Which product codes does it file in?

  • PTJPhenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K191889NG-Test CARBA 5Ng Biotech · 20191cites it

What has FDA decided for it lately?

  • K243499NG-Test® CTX-M MULTINg Biotech · 2025
  • K191889NG-Test CARBA 5Ng Biotech · 2019

All 2 as Ng Biotech →