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510(k) K253306

BioTracker 2.0 by Biotracker, LLC

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 June 26, 2026.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 26, 2026
Date Received: September 29, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No