510(k) Report

FDA applicant

Mrl Diagnostics

Cypress, CA7 decisions1994–20001 recall

FDA records 7 decisions for Mrl Diagnostics (Cypress, CA) from 1994 to 2000: 7 510(k) clearances. Most are in product codes LSR (Reagent, Borrelia Serological Reagent) and MYF (Enzyme Linked Immunosorbent Assay, Herpes…). Its devices cite 2 predicates, 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, microbiology panel, where it files most

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

FDA decisions per year

No FDA decision for Mrl Diagnostics since 2007.

Recalls per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Mrl Diagnostics 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?

  • LSRReagent, Borrelia Serological Reagent2decisions
  • MYFEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-21decision
  • LGCEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific1decision
  • LLMTest, Antigen, Nuclear, Epstein-Barr Virus1decision
  • LJNAntibody Igm, If, Epstein-Barr Virus1decision
  • MXJEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-11decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 17 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.

  • K000238HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900GMrl Diagnostics · 200014cite it
  • K993724HSV-2 Elisa Igg, Model EL0920GMrl Diagnostics · 20003cite it

What has FDA decided for it lately?

  • K000238HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900GMrl Diagnostics · 20001 recall
  • K993754HSV-1 Elisa Igg, Model EL0910GMrl Diagnostics · 2000
  • K993724HSV-2 Elisa Igg, Model EL0920GMrl Diagnostics · 2000
  • K971006Lyme Disease B. Burgdorferi Genogroup 1 Western Blot Igg (WB0400G)Mrl Diagnostics · 1998
  • K971007Lyme Disease B. Burgdorferi Genogroup 1 Western Blot Igm (WB0400M)Mrl Diagnostics · 1998
  • K946353Epstein-Barr Virus Nuclear Antigen Recombinant Immunofluorescent AssayMrl Diagnostics · 1995
  • K931520Epstein-Barr Virus Vca (Igm) Recomb Immun AntibodyMrl Diagnostics · 1994

All 7 as Mrl Diagnostics →

What has been recalled?

1 recall linked to its devices; the latest:

  • K000238HerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900G Intended for qualitatively detecting the…Jul 6, 2007