510(k) Report

FDA applicant

Thryotec

Beverly, MA1 decision2003–20031 recall

FDA records 1 decision for Thryotec (Beverly, MA) in 2003: 1 510(k) clearance. All are in product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Thryotec’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Thryotec since 2007.

Recalls per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • JLWRadioimmunoassay, Thyroid-Stimulating Hormone1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K030912Thyro TestThryotec · 20031 recall

The one decision as Thryotec →

What has been recalled?

1 recall linked to its devices; the latest:

  • K030912Thyrotest TSH POC Rapid membrane test. In vitro diagnostic.Jan 24, 2007