510(k) Report

FDA applicant

Columbia Diagnostics, Inc.

Springfield, VA2 decisions1985–19940 recalls

FDA records 2 decisions for Columbia Diagnostics, Inc. (Springfield, VA) from 1985 to 1994: 2 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and DKC (Alcohol Control Materials). 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, clinical chemistry panel, where it files most

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

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • JJYMulti-Analyte Controls, All Kinds (Assayed)1decision
  • DKCAlcohol Control Materials1decision

What has FDA decided for it lately?

  • K935819Quality Control Material (Assayed)Columbia Diagnostics, Inc. · 1994
  • K854119AccuracyColumbia Diagnostics, Inc. · 1985

All 2 as Columbia Diagnostics, Inc. →

Other applicant names beginning “Columbia”

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

Columbia Bioscience, Inc. 13Columbia Scientific, Inc. 7Columbia Medical & Surgical, Inc. 4Columbia Scientific Development, LLC 1Columbia Laboratories, Inc. 1Columbia Medical Manufacturing, LLC 1Columbia Medical Mfg, LLC 1