FDA applicant
Definitive Diagnostics, Inc.
FDA records 2 decisions for Definitive Diagnostics, Inc. (Tualatin, OR) in 1988: 2 510(k) clearances. All are in product code JSG (Culture Media, Non-Selective And…). 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 Definitive Diagnostics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Definitive Diagnostics, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Definitive Diagnostics, 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 “Definitive”
FDA records each applicant name separately; these may or may not be the same firm.