510(k) Report

FDA applicant

Inbios Intl., Inc.

Seattle, WA6 decisions1999–20110 recalls

FDA records 6 decisions for Inbios Intl., Inc. (Seattle, WA) from 1999 to 2011: 5 510(k) clearances and 1 De Novo grant. Most are in product codes DHA (System, Test, Human Chorionic Gonadotropin) and CGA (Glucose Oxidase, Glucose). 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, clinical chemistry panel, where it files most

How often FDA has decided Inbios Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Inbios Intl., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Inbios Intl., Inc.’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 “Inbios”

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