510(k) Report

FDA applicant

Actio, Inc.

Oakland, CA4 decisions1989–19900 recalls

FDA records 4 decisions for Actio, Inc. (Oakland, CA) from 1989 to 1990: 4 510(k) clearances. Most are in product codes DIE (Heavy Metals Control Materials) 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 Actio, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Actio, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Actio, Inc.’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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