510(k) Report

FDA applicant

Applications Lab

Scarborough, ME10 decisions1985–19850 recalls

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, last Nov 3, 2026

FIG. A — Illustration, immunology panel, where it files most

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.

FIG. 1 — Applications Lab by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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