510(k) Report

FDA applicant

Lederle Laboratories

Mchenry, IL3 decisions1976–19770 recalls

FDA records 3 decisions for Lederle Laboratories (Mchenry, IL) from 1976 to 1977: 3 510(k) clearances. Most are in product codes JQC (Centrifuges (Micro, Ultra, Refrigerated) For…) and DIC (Alcohol Dehydrogenase, Specific Reagent For…). 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 Lederle Laboratories’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lederle Laboratories since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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