FDA applicant
Syva Co., Dade Behring, Inc.
FDA records 19 decisions for Syva Co., Dade Behring, Inc. (San Jose, CA) from 2000 to 2001: 19 510(k) clearances. Most are in product codes KXS (Radioimmunoassay, Methaqualone) and LCD (Enzyme Immunoassay, Gentamicin). 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Syva Co., Dade Behring, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Syva Co., Dade Behring, Inc. since 2007.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Syva Co., Dade Behring, 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 “Syva”
FDA records each applicant name separately; these may or may not be the same firm.