510(k) Report

FDA applicant

Axis-Shield Biochemicals, Asa

San Diego, CA2 decisions2000–20040 recalls

FDA records 2 decisions for Axis-Shield Biochemicals, Asa (San Diego, CA) from 2000 to 2004: 2 510(k) clearances. Most are in product codes JJX (Single (Specified) Analyte Controls (Assayed…) and CDD (Radioassay, Vitamin B12). Its devices cite 1 predicate, 0 of them its own earlier devices. 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-Shield Biochemicals, Asa’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Axis-Shield Biochemicals, Asa since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Axis-Shield 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?

  • JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)1decision
  • CDDRadioassay, Vitamin B121decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

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.

  • K030655Holotc RiaAxis-Shield Biochemicals, Asa · 20041cites it

What has FDA decided for it lately?

  • K030655Holotc RiaAxis-Shield Biochemicals, Asa · 2004
  • K001651Bio-Rad %CDT TiaAxis-Shield Biochemicals, Asa · 2000

All 2 as Axis-Shield Biochemicals, Asa →

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