FDA applicant

Medical Laboratory Automation Systems, Inc.

Pleasantville, NY17 decisions1978–19960 recalls

FDA records 17 decisions for Medical Laboratory Automation Systems, Inc. (Pleasantville, NY) from 1978 to 1996: 17 510(k) clearances. Most are in product codes GKP (Instrument, Coagulation, Automated) and JPA (System, Multipurpose For In Vitro Coagulation…). Its devices cite 1 predicate, 1 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, hematology panel, where it files most

How often FDA has decided Medical Laboratory Automation Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medical Laboratory Automation Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Medical Laboratory Automation Systems, 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?