EarliPoint
K-Number: K230337 · 2023-06-29
Device Summary
Frequently Asked Questions
What is the EarliPoint?
EarliPoint is a medical device that received FDA 510(k) clearance on 2023-06-29. The listed applicant is Earlitec Diagnostics, Inc.. The 510(k) number is K230337.
When did EarliPoint receive FDA 510(k) clearance?
EarliPoint received FDA 510(k) clearance on 2023-06-29, under 510(k) number K230337.
Who is the listed applicant for EarliPoint?
The FDA 510(k) record lists Earlitec Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EarliPoint?
The FDA product code for EarliPoint is QPF.
Other records listing Earlitec Diagnostics, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: QPF)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.