FDA applicant
Dade Behring, Inc.
FDA records 344 decisions for Dade Behring, Inc. (Newark, DE) from 1978 to 2010: 343 510(k) clearances and 1 original PMA approval. Most are in product codes LON (System, Test, Automated, Antimicrobial…) and JIT (Calibrator, Secondary). Its devices cite 354 predicates, 164 of them its own earlier devices. 159 recalls are linked to its devices, 11 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Dade Behring, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2010
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like 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 “Dade”
FDA records each applicant name separately; these may or may not be the same firm.