Aptima Neisseria gonorrhoeae Assay— 510(k) K231329
Substantially EquivalentHologic, Inc.
FDA 510(k) clearance K231329 for Aptima Neisseria gonorrhoeae Assay, Substantially Equivalent on 2024-01-26. Applicant: Hologic, Inc..
Clearance details
- Applicant
- Hologic, Inc.
- Product code
- Code LSL
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.