FDA applicant

InBios International, Inc.

Seattle, WA7 decisions2014–20250 recalls

FDA records 7 decisions for InBios International, Inc. (Seattle, WA) from 2014 to 2025: 5 510(k) clearances and 2 De Novo grants. Most are in product codes QFO (Zika Virus Serological Reagents) and MIU (Enzyme Linked Immunosorbent Assay, T. Cruzi). 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 InBios International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — InBios International, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “InBios”

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

Inbios Intl., Inc. 6

InBios International, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “InBios”