EarliPoint System
K-Number: K243891 · 2025-03-26
ApplicantEarlitec Diagnostics
Decision Date2025-03-26
Product CodeQPF
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
EarliPoint System is a medical device manufactured by Earlitec Diagnostics. It received FDA 510(k) clearance on 2025-03-26 under approval number K243891. 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 System?
EarliPoint System is a medical device that received FDA 510(k) clearance on 2025-03-26. It is manufactured by Earlitec Diagnostics. The 510(k) number is K243891.
When was EarliPoint System approved by the FDA?
EarliPoint System received FDA 510(k) clearance on 2025-03-26, under approval number K243891.
What company makes EarliPoint System?
EarliPoint System is manufactured by Earlitec Diagnostics.
What is the FDA product code for EarliPoint System?
The FDA product code for EarliPoint System 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.