FDA applicant
Orion Diagnostica, Inc.
FDA records 32 decisions for Orion Diagnostica, Inc. (Mchenry, IL) from 1980 to 2016: 32 510(k) clearances. Most are in product codes LIQ (Enzyme Linked Immunoabsorbent Assay, Rotavirus) and GON (Antigen, Cf (Including Cf Control), Rubella). No recall is linked to its devices.
FDA’s records also spell it “Orion Diagnostica, OY”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Orion Diagnostica, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2016
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Orion Diagnostica, 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 “Orion”
FDA records each applicant name separately; these may or may not be the same firm.