BioTracker 2.0
FDA 510(k) clearance K253306 · decided 2026-06-26
Clearance details
- K-number
- K253306
- Device name
- BioTracker 2.0
- Applicant
- Biotracker, LLC
- Decision
- Substantially Equivalent
- Date received
- 2025-09-29
- Decision date
- 2026-06-26
- Days to decision
- 270 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.