K252269
- 510(k) number
- K252269
- Device name
- FINDER Flu A&B/SARS-CoV-2 Test
- Applicant
- Baebies, Inc. NC · US
- Product code
- QOF — Multi-Target Respiratory Specimen Nucleic Acid Test
- Decision date
- 2026-03-30
- Date received
- 2025-07-21
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K252269.pdf
Official FDA record: K252269
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.