FDA applicant

Elitechgroup

Bothell, WA18 decisions2011–20181 recall

FDA records 18 decisions for Elitechgroup (Bothell, WA) from 2011 to 2018: 18 510(k) clearances. Most are in product codes JIX (Calibrator, Multi-Analyte Mixture) and JHW (U.V. Method, Cpk Isoenzymes). Its devices cite 36 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Elitechgroup, Inc.”.

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’s devices, and how often a recall has named them.

FDA decisions per year

2in 2018

2011high 6 (2011) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

1in 2013

2011high 1 (2013) · low 0 (2011)2026

Class I Class II/III not classified

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

Planning a device like Elitechgroup’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 Vital Scientific BV 1 Elitechgroup Seppim S.A.S. 1 Elitechgroup Epoch Biosciences 1

Elitechgroup

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Elitechgroup”