FDA applicant
Ciba Corning Diagnostics Corp.
FDA records 125 decisions for Ciba Corning Diagnostics Corp. (East Walpole, MA) from 1986 to 1996: 125 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and JJE (Analyzer, Chemistry (Photometric, Discrete)…). Its devices cite 3 predicates, 3 of them its own earlier devices. 24 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ciba Corning Diagnostics Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Ciba Corning Diagnostics Corp. since 2007.
Recalls per year
1in 2023
Class I Class II/III not classified
Planning a device like Ciba Corning 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 “Ciba”
FDA records each applicant name separately; these may or may not be the same firm.