NeuMoDx CT/NG Assay 2.0— 510(k) K230267

Name: FDA 510(k) clearance K230267
Creator: U.S. Food and Drug Administration
Published: 2023-12-22

Substantially Equivalent

Neumodx Molecular, Inc.

FDA 510(k) clearance K230267 for NeuMoDx CT/NG Assay 2.0, Substantially Equivalent on 2023-12-22. Applicant: Neumodx Molecular, Inc.. Device class: 2.

Clearance details

Applicant: Neumodx Molecular, Inc.
Product code: Code QEP
Device class: Class 2
Regulation: 21 CFR 866.3393
Advisory panel: Microbiology
Date received: 2023-01-31
Decision date: 2023-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

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