FDA applicant
Casco Standards
FDA records 38 decisions for Casco Standards (Yarmouth, ME) from 1984 to 1998: 38 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and JJX (Single (Specified) Analyte Controls (Assayed…). 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 Casco Standards’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Casco Standards since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Casco Standards’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 “Casco”
FDA records each applicant name separately; these may or may not be the same firm.