FDA applicant

Bio-Whittaker, Inc., A Cambrex Co.

Walkersville, MD3 decisions1995–19970 recalls

FDA records 3 decisions for Bio-Whittaker, Inc., A Cambrex Co. (Walkersville, MD) from 1995 to 1997: 3 510(k) clearances. Most are in product codes LGD (Enzyme Linked Immunoabsorbent Assay…) and KIR (Cells, Animal And Human, Cultured). 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 Bio-Whittaker, Inc., A Cambrex Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bio-Whittaker, Inc., A Cambrex Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bio-Whittaker, Inc., A Cambrex Co.’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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Bio-Whittaker, Inc., A Cambrex Co.

Which product codes does it file in?

What has FDA decided for it lately?