510(k) Report

FDA applicant

Casco Standards

Yarmouth, ME38 decisions1984–19980 recalls

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, last Nov 3, 2026

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

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.

FIG. 1 — Casco Standards 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”

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