K243396
- 510(k) number
- K243396
- Device name
- Aptima SARS-CoV-2 Assay
- Applicant
- Hologic, Inc. CA · US
- Product code
- QQX — Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
- Decision date
- 2025-02-13
- Date received
- 2024-10-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 3.6 MB · U.S. public domain
Also available from FDA: K243396.pdf
Official FDA record: K243396
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.