510(k) Report

FDA applicant

Quantrx Biomedical Corporation

San Diego, CA4 decisions2007–20090 recalls

FDA records 4 decisions for Quantrx Biomedical Corporation (San Diego, CA) from 2007 to 2009: 4 510(k) clearances. Most are in product codes LAF (Gas Chromatography, Methamphetamine) and DIO (Enzyme Immunoassay, Cocaine And Cocaine…). Its devices cite 6 predicates, 0 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 toxicology panel, where it files most

How often FDA has decided Quantrx Biomedical Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2009

2007: 12008: 12009: 2
2007high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Quantrx Biomedical Corporation’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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