510(k) Report

FDA applicant

Advantage Diagnostics Corp.

Redwood City, CA10 decisions1988–20030 recalls

FDA records 10 decisions for Advantage Diagnostics Corp. (Redwood City, CA) from 1988 to 2003: 10 510(k) clearances. Most are in product codes DIO (Enzyme Immunoassay, Cocaine And Cocaine…) and LDJ (Enzyme Immunoassay, Cannabinoids). 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 toxicology panel, where it files most

How often FDA has decided Advantage Diagnostics Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Advantage Diagnostics Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Advantage Diagnostics Corp.’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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Other applicant names beginning “Advantage”

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