K230267
- 510(k) number
- K230267
- Device name
- NeuMoDx CT/NG Assay 2.0
- Applicant
- Neumodx Molecular, Inc. MI · US
- Product code
- QEP — Nucleic Acid Detection System For Non-Viral Microorg
- Decision date
- 2023-12-22
- Date received
- 2023-01-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
510(k) Summary (official FDA PDF): K230267.pdf
Official FDA record: K230267
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.