510(k) Report

FDA applicant

Actech Advanced Clinical Technologies, Inc.

Norwood,1 decision1990–19900 recalls

FDA records 1 decision for Actech Advanced Clinical Technologies, Inc. (Norwood,) in 1990: 1 original PMA approval. All are in product code MCL (Kit, Test, In Vitro Periodontal). 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 Actech Advanced Clinical Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Actech Advanced Clinical Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Actech Advanced Clinical Technologies…’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?

  • MCLKit, Test, In Vitro Periodontal1decision

What has FDA decided for it lately?

  • P870059Periocheck TM Enzyme Activity Test KitActech Advanced Clinical Technologies, Inc. · 1990

The one decision as Actech Advanced Clinical Technologies, Inc. →