510(k) Report

FDA applicant

Whittaker Bioproducts, Inc.

Walkersville, MD30 decisions1984–19920 recalls

FDA records 30 decisions for Whittaker Bioproducts, Inc. (Walkersville, MD) from 1984 to 1992: 30 510(k) clearances. Most are in product codes LSE (Epstein-Barr Virus, Other) and LSR (Reagent, Borrelia Serological Reagent). 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 Whittaker Bioproducts, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Whittaker Bioproducts, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Whittaker”

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