K252387
- 510(k) number
- K252387
- Device name
- Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)
- Applicant
- Diasorin Molecular, LLC CA · US
- Product code
- QOF — Multi-Target Respiratory Specimen Nucleic Acid Test
- Decision date
- 2025-10-30
- Date received
- 2025-07-31
- 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: K252387.pdf
Official FDA record: K252387
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.