510(k) Report

FDA applicant

Bio Automed Systems, Inc.

Sunnyvale, CA1 decision1985–19850 recalls

FDA records 1 decision for Bio Automed Systems, Inc. (Sunnyvale, CA) in 1985: 1 510(k) clearance. All are in product code JJQ (Colorimeter, Photometer, Spectrophotometer For…). 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 Bio Automed Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bio Automed Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bio Automed Systems, Inc. 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?

  • JJQColorimeter, Photometer, Spectrophotometer For Clinical Use1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K853453Bio Automed Sys Chemistry Analyzer Auto-LoaderBio Automed Systems, Inc. · 19851cites it

What has FDA decided for it lately?

  • K853453Bio Automed Sys Chemistry Analyzer Auto-LoaderBio Automed Systems, Inc. · 1985

The one decision as Bio Automed Systems, Inc. →