510(k) Report

FDA applicant

Diasource Immunoassays, S.A.

Davis, CA1 decision2013–20131 recall

FDA records 1 decision for Diasource Immunoassays, S.A. (Davis, CA) in 2013: 1 510(k) clearance. All are in product code MRG (System, Test, Vitamin D). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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 Diasource Immunoassays, S.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2018

2018: 1
2013high 1 (2018) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Diasource Immunoassays, S.A. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MRGSystem, Test, Vitamin D1decision

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K12336425OH Vitamin D Total Elisa TestDiasource Immunoassays, S.A. · 20131 recall

The one decision as Diasource Immunoassays, S.A. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K123364R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971Sep 11, 2018Class III