FDA applicant

Columbia Bioscience, Inc.

Columbia, MD13 decisions1996–19993 recalls

FDA records 13 decisions for Columbia Bioscience, Inc. (Columbia, MD) from 1996 to 1999: 13 510(k) clearances. Most are in product codes LSE (Epstein-Barr Virus, Other) and JZO (System, Test, Thyroid Autoantibody). Its devices cite 5 predicates, 0 of them its own earlier devices. 3 recalls are 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 Columbia Bioscience, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Columbia Bioscience, Inc. since 2007.

Recalls per year

1in 2018

2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Columbia Bioscience, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Columbia”

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

Columbia Scientific, Inc. 7 Columbia Medical & Surgical, Inc. 4 Columbia Diagnostics, Inc. 2 Columbia Scientific Development, LLC 1 Columbia Laboratories, Inc. 1 Columbia Medical Manufacturing, LLC 1 Columbia Medical Mfg, LLC 1

Columbia Bioscience, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Columbia”