FDA applicant

Id-Fish Technology, Inc.

Milpitas, CA3 decisions2017–20250 recalls

FDA records 3 decisions for Id-Fish Technology, Inc. (Milpitas, CA) from 2017 to 2025: 2 510(k) clearances and 1 De Novo grant. Most are in product codes LSR (Reagent, Borrelia Serological Reagent) and PYN (Fish (Fluorescence In Situ Hybridization) Kit…). Its devices cite 2 predicates, 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 Id-Fish Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Id-Fish Technology, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Id-Fish Technology, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?