FDA applicant
Chiron Diagnostics Corp.
FDA records 20 decisions for Chiron Diagnostics Corp. (Medfield, MA) from 1997 to 1999: 20 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and MOI (System, Test, Immunological, Antigen, Tumor). Its devices cite 5 predicates, 0 of them its own earlier devices. 14 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Chiron Diagnostics Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Chiron Diagnostics Corp. since 2007.
Recalls per year
3in 2021
Class I Class II/III not classified
Planning a device like Chiron Diagnostics Corp.’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 “Chiron”
FDA records each applicant name separately; these may or may not be the same firm.