FDA applicant

Trace Scientific, Ltd.

Clayton, Vic 3168, AU55 decisions1986–19980 recalls

FDA records 55 decisions for Trace Scientific, Ltd. (Clayton, Vic 3168, AU) from 1986 to 1998: 55 510(k) clearances. Most are in product codes CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme…) and CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt). Its devices cite 2 predicates, 0 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 Trace Scientific, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Trace Scientific, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Trace Scientific, Ltd.’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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Other applicant names beginning “Trace”

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

Trace America, Inc. 22 Trace Medical Equipment, Inc. 2 Trace Analytical 1

Trace Scientific, Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Trace”