FDA applicant

Tcpi, Inc.

Ft. Lauderdale, FL14 decisions1992–19980 recalls

FDA records 14 decisions for Tcpi, Inc. (Ft. Lauderdale, FL) from 1992 to 1998: 14 510(k) clearances. Most are in product codes JHI (Visual, Pregnancy Hcg, Prescription Use) and LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). Its devices cite 1 predicate, 1 of them its own earlier devices. 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 Tcpi, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tcpi, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Tcpi, Inc.

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?