510(k) Report

FDA applicant

Kent Laboratories, Inc.

Mchenry, IL40 decisions1977–19950 recalls

FDA records 40 decisions for Kent Laboratories, Inc. (Mchenry, IL) from 1977 to 1995: 40 510(k) clearances. Most are in product codes DEW (Igg, Antigen, Antiserum, Control) and DFK (Igg (Fab Fragment Specific), Antigen…). 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 Kent Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Kent 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 “Kent”

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