ARIOL HER-2/NEU IHC— 510(k) K031715

Substantially Equivalent

Applied Imaging Corp.

FDA 510(k) clearance K031715 for ARIOL HER-2/NEU IHC, Substantially Equivalent on 2004-01-08. Applicant: Applied Imaging Corp.. Device class: 2.

Clearance details

Applicant: Applied Imaging Corp.
Product code: Code NOT
Device class: Class 2
Regulation: 21 CFR 864.1860
Advisory panel: Hematology
Date received: 2003-06-02
Decision date: 2004-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K031715

K-number listed on FDA's recall record

Z-1948-2016 — Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape. This particular Ariol software application is intended to measure, count, and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed paraffin-embedded tissue specimens immunohistochemically stained for Estrogens Receptors or Progesterone Receptors (ER/PR). ER/PR results are indicated for use as and aid in the management, prognosis, and prediction of therapy outcomes of breast cancer.Class III·Terminated·Leica Biosystems Richmond Inc.·20160506

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K031715.

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