FDA 510(k)

EarliPoint System

K-Number: K213882 · 2022-06-08

Decision Date2022-06-08

Product CodeQPF

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

EarliPoint System is the device name listed in this FDA 510(k) record. The listed applicant is Earlitec Diagnostics, Inc.. It received FDA 510(k) clearance on 2022-06-08 under 510(k) number K213882. 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 2022-06-08. The listed applicant is Earlitec Diagnostics, Inc.. The 510(k) number is K213882.

When did EarliPoint System receive FDA 510(k) clearance?

EarliPoint System received FDA 510(k) clearance on 2022-06-08, under 510(k) number K213882.

Who is the listed applicant for EarliPoint System?

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 System?

The FDA product code for EarliPoint System 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.

K253442EarliPoint Assessment K243891EarliPoint System K230337EarliPoint

Related Devices (Code: QPF)

K253442EarliPoint AssessmentEarlitec Diagnostics K243558Canvas DxCognoa, Inc.K243891EarliPoint SystemEarlitec Diagnostics K230337EarliPointEarlitec Diagnostics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.