FDA applicant

Lee Laboratories, Inc.

Grayson, GA10 decisions1997–19970 recalls

FDA records 10 decisions for Lee Laboratories, Inc. (Grayson, GA) in 1997: 10 510(k) clearances. Most are in product codes GNC (Antigens, Febrile, Slide And Tube, All Groups…) and GSO (Antigens (Febrile), Agglutination, Brucella Spp.). 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, microbiology panel, where it files most

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

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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Lee Laboratories, Inc.

Which product codes does it file in?

What has FDA decided for it lately?