510(k) Report

FDA applicant

New Day Diagnostics, LLC

Knoxville1 decision2016–20161 recall

FDA records 1 decision for New Day Diagnostics, LLC (Knoxville) in 2016: 1 original PMA approval. All are in product code PHP (System, Colorectal Neoplasia, Dna Methylation…). 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, pathology panel, where it files most

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

FDA decisions per year

1in 2016

2016: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2017

2017: 1
2016high 1 (2017) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — New Day Diagnostics, LLC by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PHPSystem, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection1decision

What has FDA decided for it lately?

  • P130001Epi proColonNew Day Diagnostics, LLC · 20161 recall

The one decision as New Day Diagnostics, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • P130001Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding…Nov 2, 2017Class II