510(k) Report

FDA applicant

London Diagnostics, Inc.

Eden Prairie, MN12 decisions1988–19910 recalls

FDA records 12 decisions for London Diagnostics, Inc. (Eden Prairie, MN) from 1988 to 1991: 12 510(k) clearances. Most are in product codes CFT (Radioimmunoassay, Prolactin (Lactogen)) and CFL (Radioimmunoassay, Human Growth Hormone). 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 London Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like London 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 “London”

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