EarliPoint Assessment— 510(k) K253442
Substantially EquivalentEarlitec Diagnostics
FDA 510(k) clearance K253442 for EarliPoint Assessment, Substantially Equivalent on 2026-03-05. Applicant: Earlitec Diagnostics.
Clearance details
- Applicant
- Earlitec Diagnostics
- Product code
- Code QPF
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.