510(k) Report

FDA applicant

Future Diagnostics B.V.

San Diego, CA2 decisions2000–20011 recall

FDA records 2 decisions for Future Diagnostics B.V. (San Diego, CA) from 2000 to 2001: 2 510(k) clearances. Most are in product codes CEW (Radioimmunoassay, Parathyroid Hormone) and CKG (Radioimmunoassay, Acth). 1 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 Future Diagnostics B.V.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Future Diagnostics B.V. since 2007.

Recalls per year

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Future”

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