510(k) Report

FDA applicant

Axis Biochemicals, Asa

San Diego, CA3 decisions1998–19990 recalls

FDA records 3 decisions for Axis Biochemicals, Asa (San Diego, CA) from 1998 to 1999: 3 510(k) clearances. Most are in product codes LPS (Urinary Homocystine (Nonquantitative) Test…) and DFC (Lipoprotein, Low-Density, Antigen, Antiserum…). 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 Biochemicals, Asa’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Axis Biochemicals, Asa since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Axis Biochemicals, Asa 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?

  • LPSUrinary Homocystine (Nonquantitative) Test System2decisions
  • DFCLipoprotein, Low-Density, Antigen, Antiserum, Control1decision

Who builds on its devices?

Later devices cite its devices 4 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.

  • K980907Axis Homocysteine Enzyme ImmunoassayAxis Biochemicals, Asa · 19983cite it
  • K980812Imx HomocysteineAxis Biochemicals, Asa · 19981cites it

What has FDA decided for it lately?

  • K992274Modification to Imx HomocysteineAxis Biochemicals, Asa · 1999
  • K980907Axis Homocysteine Enzyme ImmunoassayAxis Biochemicals, Asa · 1998
  • K980812Imx HomocysteineAxis Biochemicals, Asa · 1998

All 3 as Axis Biochemicals, Asa →

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