510(k) Report

FDA applicant

Portable Diagnostic Services, Inc.

Westlake Village, CA1 decision1992–19920 recalls

FDA records 1 decision for Portable Diagnostic Services, Inc. (Westlake Village, CA) in 1992: 1 510(k) clearance. All are in product code CEM (Electrode, Ion Specific, Potassium). 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 Portable Diagnostic Services, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Portable Diagnostic Services, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Portable Diagnostic Services, 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?

  • CEMElectrode, Ion Specific, Potassium1decision

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.

  • K915345Stat K SystemPortable Diagnostic Services, Inc. · 19921cites it

What has FDA decided for it lately?

  • K915345Stat K SystemPortable Diagnostic Services, Inc. · 1992

The one decision as Portable Diagnostic Services, Inc. →

Other applicant names beginning “Portable”

FDA records each applicant name separately; these may or may not be the same firm.

Portable Power Systems, Inc. 18Portable Medical Laboratories, Inc. 9Portable Therapeutix 2Portable Ophthalmic Devices, Inc. 1Portable Travtion Device Co. 1