Concentriq AP-Dx— 510(k) K261380

Substantially Equivalent

Proscia, Inc.

FDA 510(k) clearance K261380 for Concentriq AP-Dx, Substantially Equivalent on 2026-08-05. Applicant: Proscia, Inc.. Device class: 2.

Clearance details

Applicant: Proscia, Inc.
Product code: Code QKQ
Device class: Class 2
Regulation: 21 CFR 864.3700
Advisory panel: Pathology
Date received: 2026-04-27
Decision date: 2026-08-05
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.