510(k) Report

FDA applicant

Mp Biomedicals, LLC

Northridge, CA2 decisions2006–20170 recalls

FDA records 2 decisions for Mp Biomedicals, LLC (Northridge, CA) from 2006 to 2017: 2 510(k) clearances. Most are in product codes DJG (Enzyme Immunoassay, Opiates) and DIO (Enzyme Immunoassay, Cocaine And Cocaine…). Its devices cite 4 predicates, 1 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 toxicology panel, where it files most

How often FDA has decided Mp Biomedicals, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mp Biomedicals, LLC 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?

  • DJGEnzyme Immunoassay, Opiates1decision
  • DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K051958MP Rapidoxy Test Strip, Model 07RD-7073Mp Biomedicals, LLC · 20061cites it

What has FDA decided for it lately?

  • K162395MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test CupMp Biomedicals, LLC · 2017
  • K051958MP Rapidoxy Test Strip, Model 07RD-7073Mp Biomedicals, LLC · 2006

All 2 as Mp Biomedicals, LLC →