K253306Substantially Equivalent
BioTracker 2.0
Biotracker, LLC, Miami FL / Traditional, Substantially Equivalent
K253306 is the FDA 510(k) clearance record for BioTracker 2.0, cleared for Biotracker, LLC on . FDA records list one 510(k) clearance for Biotracker, LLC. As of , FDA records show no recalls naming K253306.
Clearance record
- Decision date
- Received
- (270 days to decision)
- Review panel
- Unknown
- Applicant
- Biotracker, LLC 19900 E Country Club Dr., Suite 04, Miami FL
- 510(k) summary
- Summary PDF
- Third party review
- No
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