FDA applicant

Elitechgroup Vital Scientific BV

Bothell, WA1 decision2011–20114 recalls

FDA records 1 decision for Elitechgroup Vital Scientific BV (Bothell, WA) in 2011: 1 510(k) clearance. All are in product code JGS (Electrode, Ion Specific, Sodium). Its devices cite 5 predicates, 0 of them its own earlier devices. 4 recalls are 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 Elitechgroup Vital Scientific BV’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2016

2011high 2 (2012) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Elitechgroup Vital Scientific BV by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Elitechgroup Vital Scientific BV’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Elitechgroup”

FDA records each applicant name separately; these may or may not be the same firm.

Elitechgroup 18 Elitechgroup Seppim S.A.S. 1 Elitechgroup Epoch Biosciences 1

Elitechgroup Vital Scientific BV

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Elitechgroup”