510(k) Report

FDA applicant

Axis

San Diego, CA1 decision1999–19990 recalls

FDA records 1 decision for Axis (San Diego, CA) in 1999: 1 510(k) clearance. All are in product code NAO (Test, Carbohydrate Deficient Transferrin). 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 Axis’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Axis since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Axis 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?

  • NAOTest, Carbohydrate Deficient Transferrin1decision

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.

  • K992502Axis %CDT Turbidimetric ImmunoassayAxis · 19991cites it

What has FDA decided for it lately?

  • K992502Axis %CDT Turbidimetric ImmunoassayAxis · 1999

The one decision as Axis →

Other applicant names beginning “Axis”

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-Shield Doc AS 1Axis Surgical Technologies, Inc. 1Axis Health Care, LLC 1