510(k) Report

FDA applicant

Benchmark Reagents

Australia, AU1 decision1987–19870 recalls

FDA records 1 decision for Benchmark Reagents (Australia, AU) in 1987: 1 510(k) clearance. All are in product code JQE (Resin, Ion-Exchange, Ascorbic Acid…). 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 Benchmark Reagents’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Benchmark Reagents since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Benchmark Reagents’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report