New Day Diagnostics, LLC: FDA filings under this applicant name

FDA lists 0 510(k) clearances under the applicant name “New Day Diagnostics, LLC”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

Top product codes

Review panels

• Pathology (1)

PMA and De Novo decisions

Recalls

openFDA lists no recalls under a recalling firm named New Day Diagnostics, LLC.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Frequently asked questions

How many FDA 510(k) clearances are listed under New Day Diagnostics, LLC?

FDA lists 0 510(k) clearances under the applicant name “New Day Diagnostics, LLC”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.

Which FDA product codes appear under New Day Diagnostics, LLC?

The most frequent FDA product codes under this applicant name are PHP (System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection, 1).

Next steps

• See all 0 New Day Diagnostics, LLC clearances with predicates and recalls
• Run predicate analysis for product code PHP, New Day Diagnostics, LLC's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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