FDA applicant
Diasys Diagnostic Systems GmbH
FDA records 1 decision for Diasys Diagnostic Systems GmbH (Holzheim, DE) in 2025: 1 510(k) clearance. All are in product code PTF (Assay To Measure Pct To Aid In The Risk…). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Diasys Diagnostic Systems GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like Diasys Diagnostic Systems GmbH’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 “Diasys”
FDA records each applicant name separately; these may or may not be the same firm.