510(k) Report

FDA applicant

Gentian AS

San Diego, CA2 decisions2007–20081 recall

FDA records 2 decisions for Gentian AS (San Diego, CA) from 2007 to 2008: 2 510(k) clearances. All are in product code NDY (Test, Cystatin C). Its devices cite 2 predicates, 1 of them its own earlier devices. 1 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 Gentian AS’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Gentian AS 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?

  • NDYTest, Cystatin C2decisions

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.

  • K071388Gentian Cystatin C ImmunoassayGentian AS · 20071cites it

What has FDA decided for it lately?

  • K081875Gentian Cystatin C ImmunoassayGentian AS · 20081 recall
  • K071388Gentian Cystatin C ImmunoassayGentian AS · 20071 recall

All 2 as Gentian AS →

What has been recalled?

1 recall linked to its devices; the latest:

  • K081875GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C…Sep 2, 2020Class II