510(k) Report

FDA applicant

Pharmacia & Upjohn Co.

Westervillle, OH18 decisions1996–20002 recalls

FDA records 18 decisions for Pharmacia & Upjohn Co. (Westervillle, OH) from 1996 to 2000: 18 510(k) clearances. Most are in product codes DHB (System, Test, Radioallergosorbent (Rast)…) and JZO (System, Test, Thyroid Autoantibody). Its devices cite 10 predicates, 0 of them its own earlier devices. 2 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, immunology panel, where it files most

How often FDA has decided Pharmacia & Upjohn Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pharmacia & Upjohn Co. since 2007.

Recalls per year

2in 2017

2017: 2
2007high 2 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Pharmacia & Upjohn 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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Other applicant names beginning “Pharmacia”

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