FDA applicant

Lerner Laboratories, Inc.

Mchenry, IL5 decisions1976–19850 recalls

FDA records 5 decisions for Lerner Laboratories, Inc. (Mchenry, IL) from 1976 to 1985: 5 510(k) clearances. Most are in product codes KEM (Agent, Clearing) and LEA (Preservative, Cytological). 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, pathology panel, where it files most

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

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Lerner 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 “Lerner”

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

Lerner Medical Devices, Inc. 3 Lerner Medical, Inc. 1

Lerner Laboratories, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Lerner”