FDA applicant

Elitechgroup Epoch Biosciences

Bothell, WA1 decision2013–20130 recalls

FDA records 1 decision for Elitechgroup Epoch Biosciences (Bothell, WA) in 2013: 1 510(k) clearance. All are in product code NQX (System, Nucleic Acid Amplification Test, Dna…). Its devices cite 1 predicate, 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, microbiology panel, where it files most

How often FDA has decided Elitechgroup Epoch Biosciences’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Elitechgroup Epoch Biosciences by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

Elitechgroup Epoch Biosciences

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Elitechgroup”