ACTOnco, ACTOnco IVD— 510(k) K210017

Substantially Equivalent

Act Genomics

FDA 510(k) clearance K210017 for ACTOnco, ACTOnco IVD, Substantially Equivalent on 2022-12-23. Applicant: Act Genomics. Device class: 2.

Clearance details

Applicant: Act Genomics
Product code: Code PZM
Device class: Class 2
Regulation: 21 CFR 866.6080
Advisory panel: Pathology
Date received: 2021-01-04
Decision date: 2022-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code PZM

K260235 — CellDx-Tissue2026-05-12
K241868 — xR IVD2025-09-19
K250003 — GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)2025-08-29
K202304 — NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)2021-07-14
K192063 — PGDx elio tissue complete2020-04-24

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