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. Device class: 2.
Clearance details
- Applicant
- Earlitec Diagnostics
- Product code
- Code QPF
- Device class
- Class 2
- Regulation
- 21 CFR 882.1491
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Recent devices under product code QPF
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