510(k) Report

FDA applicant

The Upjohn Co.

Kalamazoo9 decisions1968–19900 recalls

FDA records 9 decisions for The Upjohn Co. (Kalamazoo) from 1968 to 1990: 6 510(k) clearances and 3 original PMA approvals. Most are in product codes JTT (Susceptibility Test Powders, Antimicrobial) and LOP (Solution, Antimicrobial). 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 The Upjohn Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for The Upjohn Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like The 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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