EarliPoint
K-Number: K230337 · 2023-06-29
ApplicantEarlitec Diagnostics, Inc.
Decision Date2023-06-29
Product CodeQPF
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
EarliPoint is a medical device manufactured by Earlitec Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-06-29 under approval number K230337. 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?
EarliPoint is a medical device that received FDA 510(k) clearance on 2023-06-29. It is manufactured by Earlitec Diagnostics, Inc.. The 510(k) number is K230337.
When was EarliPoint approved by the FDA?
EarliPoint received FDA 510(k) clearance on 2023-06-29, under approval number K230337.
What company makes EarliPoint?
EarliPoint is manufactured by Earlitec Diagnostics, Inc..
What is the FDA product code for EarliPoint?
The FDA product code for EarliPoint is QPF.
Other Devices by Earlitec Diagnostics, Inc.
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.