Cleared Traditional

K141109 - APERIO EPATHOLOGY EIHC IVD SYSTEM (FDA 510(k) Clearance)

K141109 · Leica Biosystems Imaging, Inc. · Pathology device
Jul 2014
Decision
91d
Days
-
Risk

K141109 is an FDA 510(k) clearance for the APERIO EPATHOLOGY EIHC IVD SYSTEM..

Submitted by Leica Biosystems Imaging, Inc. (Vista, US). The FDA issued a Cleared decision on July 29, 2014, 91 days after receiving the submission on April 29, 2014.

This device falls under the Pathology FDA review panel.

Submission Details

510(k) Number K141109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2014
Decision Date July 29, 2014
Days to Decision 91 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

Product Code NOT
Device Class -