K252932
- 510(k) number
- K252932
- Device name
- Fast PCR Mini Respiratory Panel
- Applicant
- Autonomous Medical Devices Incorporated CA · US
- Product code
- QOF — Multi-Target Respiratory Specimen Nucleic Acid Test
- Decision date
- 2026-06-12
- Date received
- 2025-09-15
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain
Also available from FDA: K252932.pdf
Official FDA record: K252932
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.