FDA applicant
Bayer Diagnostics Corp.
FDA records 32 decisions for Bayer Diagnostics Corp. (Tarrytown, NY) from 2000 to 2003: 32 510(k) clearances. Most are in product codes JIF (Enzymatic Method, Ammonia) and JJY (Multi-Analyte Controls, All Kinds (Assayed)). Its devices cite 23 predicates, 0 of them its own earlier devices. 29 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Bayer Diagnostics Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Bayer Diagnostics Corp. since 2007.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Bayer 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 “Bayer”
FDA records each applicant name separately; these may or may not be the same firm.