510(k) K253306
K253306 is an FDA 510(k) premarket notification submitted by Biotracker, LLC for the device "BioTracker 2.0". The FDA issued a decision of Substantially Equivalent on Jun 26, 2026.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 26, 2026
- Date Received
- Sep 29, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No