510(k) Report

FDA applicant

Axis-Shield Doc AS

San Diego, CA1 decision1995–19950 recalls

FDA records 1 decision for Axis-Shield Doc AS (San Diego, CA) in 1995: 1 510(k) clearance. All are in product code GGW (Test, Time, Partial Thromboplastin). 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 Axis-Shield Doc AS’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Axis-Shield Doc AS since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Axis-Shield Doc AS 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?

  • GGWTest, Time, Partial Thromboplastin1decision

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.

  • K945940Coatest (R) Apc (TM) ResistanceAxis-Shield Doc AS · 19951cites it

What has FDA decided for it lately?

  • K945940Coatest (R) Apc (TM) ResistanceAxis-Shield Doc AS · 1995

The one decision as Axis-Shield Doc AS →

Other applicant names beginning “Axis-Shield”

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

Axis-Shield Diagnostics, Ltd. 28Axis-Shield Poc AS 4Axis-Shield, Ltd. 3Axis Biochemicals, Asa 3Axis Orthopaedics 3Axis-Shield Biochemicals, Asa 2Axis Spine Technologies, Ltd. 2Axis Surgical Technologies, Inc. 1Axis 1Axis Health Care, LLC 1