510(k) Report

FDA applicant

Biowhittaker Molecular Applications, Inc.

Walkersville, MD10 decisions1992–19960 recalls

FDA records 10 decisions for Biowhittaker Molecular Applications, Inc. (Walkersville, MD) from 1992 to 1996: 10 510(k) clearances. Most are in product codes JJQ (Colorimeter, Photometer, Spectrophotometer For…) and LLL (Extractable Antinuclear Antibody, Antigen And…). 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 Biowhittaker Molecular Applications, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biowhittaker Molecular Applications, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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