K231329
- 510(k) number
- K231329
- Device name
- Aptima Neisseria gonorrhoeae Assay
- Applicant
- Hologic, Inc. CA · US
- Product code
- LSL — Dna-Reagents, Neisseria
- Decision date
- 2024-01-26
- Date received
- 2023-05-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K231329.pdf
Official FDA record: K231329
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.