510(k) Report

FDA applicant

Casco-Nerl Diagnostics Corporation (Maine)

Portland, ME3 decisions1999–20000 recalls

FDA records 3 decisions for Casco-Nerl Diagnostics Corporation (Maine) (Portland, ME) from 1999 to 2000: 3 510(k) clearances. All are in product code JJY (Multi-Analyte Controls, All Kinds (Assayed)). Its devices cite 2 predicates, 1 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, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Casco-Nerl Diagnostics Corporation (Maine)’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Casco-Nerl Diagnostics Corporation (Maine) since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Casco-Nerl Diagnostics Corporation (Maine) by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Casco-Nerl”

FDA records each applicant name separately; these may or may not be the same firm.