K233352
- 510(k) number
- K233352
- Device name
- Aptima HCV Quant Dx Assay
- Applicant
- Hologic, Inc. CA · US
- Product code
- MZP — Assay, Hybridization And/Or Nucleic Acid Amplificati
- Decision date
- 2024-07-24
- Date received
- 2023-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K233352.pdf
Official FDA record: K233352
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.