510(k) Report

FDA applicant

Ani Biotech OY

Beverly, MA1 decision2006–20060 recalls

FDA records 1 decision for Ani Biotech OY (Beverly, MA) in 2006: 1 510(k) clearance. All are in product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). Its devices cite 1 predicate, 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 Ani Biotech OY’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ani Biotech OY since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ani Biotech OY’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LCXKit, Test, Pregnancy, Hcg, Over The Counter1decision

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?

  • K053138Myset Pregnancy TestAni Biotech OY · 2006

The one decision as Ani Biotech OY →