FDA applicant
Applications Lab
FDA records 10 decisions for Applications Lab (Scarborough, ME) in 1985: 10 510(k) clearances. Most are in product codes DEW (Igg, Antigen, Antiserum, Control) and DCK (C-Reactive Protein, Antigen, Antiserum, And…). 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 Applications Lab’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Applications Lab since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Applications Lab’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