510(k) Report

FDA applicant

Sakers, Inc.

Blackwood, NJ2 decisions1989–19890 recalls

FDA records 2 decisions for Sakers, Inc. (Blackwood, NJ) in 1989: 2 510(k) clearances. Most are in product codes LDJ (Enzyme Immunoassay, Cannabinoids) and DMN (Thin Layer Chromatography, Cocaine). 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 Sakers, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sakers, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sakers, 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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