FDA applicant

Sun Biomedical Laboratories, Inc.

Blackwood, NJ17 decisions1994–20030 recalls

FDA records 17 decisions for Sun Biomedical Laboratories, Inc. (Blackwood, NJ) from 1994 to 2003: 17 510(k) clearances. Most are in product codes LDJ (Enzyme Immunoassay, Cannabinoids) and DKZ (Enzyme Immunoassay, Amphetamine). 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 Sun Biomedical Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sun Biomedical Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sun Biomedical Laboratories, Inc.’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

Sun Biomedical Laboratories, Inc.

Which product codes does it file in?

What has FDA decided for it lately?