APERIO EPATHOLOGY EIHC IVD SYSTEM— 510(k) K141109

Name: FDA 510(k) clearance K141109
Creator: U.S. Food and Drug Administration
Published: 2014-07-29

Substantially Equivalent

Leica Biosystems Imaging, Inc.

FDA 510(k) clearance K141109 for APERIO EPATHOLOGY EIHC IVD SYSTEM, Substantially Equivalent on 2014-07-29. Applicant: Leica Biosystems Imaging, Inc.. Device class: 2.

Clearance details

Applicant: Leica Biosystems Imaging, Inc.
Product code: Code NOT
Device class: Class 2
Regulation: 21 CFR 864.1860
Advisory panel: Hematology
Date received: 2014-04-29
Decision date: 2014-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vista, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K141109

K-number listed on FDA's recall record

Z-0046-2020 — Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.Class II·Terminated·Leica Biosystems Imaging, Inc.·20181210

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141109.

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