K243345
- 510(k) number
- K243345
- Device name
- Aptima BV Assay; Aptima CV/TV Assay
- Applicant
- Hologic, Inc. CA · US
- Product code
- PQA — Vaginitis And Bacterial Vaginosis Nucleic Acid Detec
- Decision date
- 2024-11-25
- Date received
- 2024-10-28
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243345.pdf
Official FDA record: K243345
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.