FDA applicant
Immuno Concepts, Inc.
FDA records 36 decisions for Immuno Concepts, Inc. (Sacramento, CA) from 1981 to 2001: 36 510(k) clearances. Most are in product codes LLL (Extractable Antinuclear Antibody, Antigen And…) and DHN (Antinuclear Antibody, Indirect…). Its devices cite 13 predicates, 7 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Immuno Concepts, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Immuno Concepts, Inc. since 2007.
Recalls per year
2in 2008
Class I Class II/III not classified
Planning a device like Immuno Concepts, 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 “Immuno”
FDA records each applicant name separately; these may or may not be the same firm.