FDA applicant

Pharmacia Diagnostics, Inc.

Columbia, MD10 decisions1990–20063 recalls

FDA records 10 decisions for Pharmacia Diagnostics, Inc. (Columbia, MD) from 1990 to 2006: 10 510(k) clearances. Most are in product codes LGD (Enzyme Linked Immunoabsorbent Assay…) and LFX (Enzyme Linked Immunoabsorbent Assay, Rubella). Its devices cite 2 predicates, 0 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Pharmacia Diagnostics AB”, “Pharmacia Diagnostics GmbH & Co. KG”.

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 Pharmacia Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

1in 2019

2007high 2 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Pharmacia Diagnostics, 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 “Pharmacia”

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

Pharmacia, Inc. 130 Pharmacia Deltec, Inc. 43 Pharmacia & Upjohn Co. 18 Pharmacia Deutschland GmbH 10 Pharmacia Eni Diagnostics, Inc. 2 Pharmacia Iovision, Inc. 1 Pharmacia Hepar, Inc. 1 Pharmacia Fine Chemicals 1

Pharmacia Diagnostics, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Pharmacia”