FDA applicant

Trace America, Inc.

Miami, FL22 decisions1988–20011 recall

FDA records 22 decisions for Trace America, Inc. (Miami, FL) from 1988 to 2001: 22 510(k) clearances. Most are in product codes KHS (Enzymatic, Carbon-Dioxide) and CJE (Nitrophenylphosphate, Alkaline Phosphatase Or…). 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 Trace America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Trace America, Inc. since 2007.

Recalls per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Trace”

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

Trace Scientific, Ltd. 55 Trace Medical Equipment, Inc. 2 Trace Analytical 1

Trace America, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Trace”