EarliPoint Assessment
K-Number: K253442 · 2026-03-05
ApplicantEarlitec Diagnostics
Decision Date2026-03-05
Product CodeQPF
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
EarliPoint Assessment is a medical device manufactured by Earlitec Diagnostics. It received FDA 510(k) clearance on 2026-03-05 under approval number K253442. The device is classified under product code QPF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EarliPoint Assessment?
EarliPoint Assessment is a medical device that received FDA 510(k) clearance on 2026-03-05. It is manufactured by Earlitec Diagnostics. The 510(k) number is K253442.
When was EarliPoint Assessment approved by the FDA?
EarliPoint Assessment received FDA 510(k) clearance on 2026-03-05, under approval number K253442.
What company makes EarliPoint Assessment?
EarliPoint Assessment is manufactured by Earlitec Diagnostics.
What is the FDA product code for EarliPoint Assessment?
The FDA product code for EarliPoint Assessment is QPF.
Other Devices by Earlitec Diagnostics
Related Devices (Code: QPF)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.