K253306
- 510(k) number
- K253306
- Device name
- BioTracker 2.0
- Applicant
- Biotracker, LLC FL · US
- Decision date
- 2026-06-26
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 1.6 MB · U.S. public domain
Also available from FDA: K253306.pdf
Official FDA record: K253306
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.