FDA applicant
Inbios Intl., Inc.
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
How often FDA has decided Inbios Intl., Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2011
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
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.
See the 510(k) ReportOther applicant names beginning “Inbios”
FDA records each applicant name separately; these may or may not be the same firm.