Concentriq Dx— 510(k) K230839

Substantially Equivalent

Proscia, Inc.

FDA 510(k) clearance K230839 for Concentriq Dx, Substantially Equivalent on 2024-02-08. Applicant: Proscia, Inc.. Device class: 2.

Clearance details

Applicant: Proscia, Inc.
Product code: Code PSY
Device class: Class 2
Regulation: 21 CFR 864.3700
Advisory panel: Pathology
Date received: 2023-03-27
Decision date: 2024-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philadelphia, PA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.