FDA applicant

Clark Laboratories, Inc.

Blairstown, NJ14 decisions1992–19980 recalls

FDA records 14 decisions for Clark Laboratories, Inc. (Blairstown, NJ) from 1992 to 1998: 14 510(k) clearances. Most are in product codes LLL (Extractable Antinuclear Antibody, Antigen And…) and LSE (Epstein-Barr Virus, Other). 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, immunology panel, where it files most

How often FDA has decided Clark Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Clark Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Clark Laboratories, 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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Other applicant names beginning “Clark”

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

Clark Research and Development, Inc. 2 Clark Davis Medical Systems, Inc. 2 Clark Pool & Assoc. 1 Clark Pillow Co., Inc. 1

Clark Laboratories, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Clark”