FDA applicant
Siemens Heatlhcare Diagnostics, Inc.
FDA records 3 decisions for Siemens Heatlhcare Diagnostics, Inc. (Newark, DE) from 2010 to 2011: 3 510(k) clearances. Most are in product codes OAV (Mycophenolic Acid Test System) and LCP (Assay, Glycosylated Hemoglobin). Its devices cite 4 predicates, 0 of them its own earlier devices. 4 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Siemens Heatlhcare Diagnostics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2011
2026 so far, outlined.
Recalls per year
1in 2017
Class I Class II/III not classified
Planning a device like Siemens Heatlhcare Diagnostics, 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) Report