EarliPoint System— 510(k) K213882

Substantially Equivalent

Earlitec Diagnostics, Inc.

FDA 510(k) clearance K213882 for EarliPoint System, Substantially Equivalent on 2022-06-08. Applicant: Earlitec Diagnostics, Inc..

Clearance details

Applicant: Earlitec Diagnostics, Inc.
Product code: Code QPF
Advisory panel: Neurology
Date received: 2021-12-13
Decision date: 2022-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

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