510(k) Report

FDA applicant

Farallon Medial, Inc.

Hayward, CA1 decision2005–20050 recalls

FDA records 1 decision for Farallon Medial, Inc. (Hayward, CA) in 2005: 1 510(k) clearance. All are in product code JPA (System, Multipurpose For In Vitro Coagulation…). 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 Farallon Medial, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Farallon Medial, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Farallon Medial, 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?

  • JPASystem, Multipurpose For In Vitro Coagulation Studies1decision

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K050243Immedia Prothrombin Time SystemFarallon Medial, Inc. · 20052cite it

What has FDA decided for it lately?

  • K050243Immedia Prothrombin Time SystemFarallon Medial, Inc. · 2005

The one decision as Farallon Medial, Inc. →