510(k) Report

FDA applicant

Diamedix Corp.

Miami, FL68 decisions1986–20119 recalls

FDA records 68 decisions for Diamedix Corp. (Miami, FL) from 1986 to 2011: 68 510(k) clearances. Most are in product codes LLL (Extractable Antinuclear Antibody, Antigen And…) and LFX (Enzyme Linked Immunoabsorbent Assay, Rubella). 9 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, immunology panel, where it files most

How often FDA has decided Diamedix Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2018

2008: 22011: 12012: 22014: 22015: 12018: 1
2007high 2 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Diamedix Corp. 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?

  • LLLExtractable Antinuclear Antibody, Antigen And Control10decisions
  • LFXEnzyme Linked Immunoabsorbent Assay, Rubella5decisions
  • LSRReagent, Borrelia Serological Reagent4decisions
  • LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii4decisions
  • LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control3decisions
  • DHRSystem, Test, Rheumatoid Factor3decisions

Also: MID (3), DHN (2), CZW (2), KHW (2), LJM (2), LFY (2).

Who builds on its devices?

Later devices cite its devices 8 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.

  • K001767Diamedix IS-CMV Igm Capture Test SystemDiamedix Corp. · 20002cite it
  • K981498IS-Toxoplasma Igg Test SystemDiamedix Corp. · 19982cite it
  • K981867IS-Vzu Igg Test SystemDiamedix Corp. · 19981cites it
  • K973177Mago Automated Eia ProcessorDiamedix Corp. · 19971cites it
  • K001707Diamedix IS-Toxoplasma Igm Capture Test SystemDiamedix Corp. · 20001cites it
  • K981163Diamedix IS-CMV Igg Test SystemDiamedix Corp. · 19981cites it

What has FDA decided for it lately?

  • K093101MAGO 4SDiamedix Corp. · 2011
  • K021394Diamedix IS-Rheumatoid Factor Test SystemDiamedix Corp. · 2002
  • K013956Diamedix IS-Anti-B2 Glycoprotein I ScreenDiamedix Corp. · 2002
  • K013628Diamedix IS-Anti-B2 Glycoprotein I Igg/Igm Test SystemDiamedix Corp. · 2001
  • K012450Diamedix IS-Anti-Cardiolipin Iga Test SystemDiamedix Corp. · 2001
  • K012449Diamedix IS-Anti-Cardiolipin Igg/Igm Test SystemDiamedix Corp. · 2001
  • K012797Diamedix IS-Anti-Gliadin Iga Test SystemDiamedix Corp. · 2001
  • K012795Diamedix IS-Anti-Gliadin Igg Test SystemDiamedix Corp. · 20011 recall

All 68 as Diamedix Corp. →

What has been recalled?

9 recalls linked to its devices; the latest:

  • K981831Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog…Jan 5, 2018Class III
  • K981163Diamedix Is-CMV IgG Test KitMar 26, 2015Class II
  • K981831Diamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure…Oct 20, 2014Class II
  • K981812Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure…Oct 20, 2014Class II
  • K970220The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix…Aug 6, 2012Class II
  • K002262Product is labeled in part: "***is immunosimplicity***HSV 1&2 IgM***Enzyme Immunoassay…Jan 16, 2012