K231316
- 510(k) number
- K231316
- Device name
- Aptima Trichomonas vaginalis Assay
- Applicant
- Hologic, Inc. CA · US
- Product code
- OUY — Trichomonas Vaginalis Nucleic Acid Amplification Tes
- Decision date
- 2023-11-06
- Date received
- 2023-05-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K231316.pdf
Official FDA record: K231316
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.