NeuMoDx CT/NG Assay 2.0— 510(k) K230267
Substantially EquivalentNeumodx Molecular, Inc.
FDA 510(k) clearance K230267 for NeuMoDx CT/NG Assay 2.0, Substantially Equivalent on 2023-12-22. Applicant: Neumodx Molecular, Inc..
Clearance details
- Applicant
- Neumodx Molecular, Inc.
- Product code
- Code QEP
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ann Arbor, MI, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.