Cleared Traditional

APERIO EPATHOLOGY EIHC IVD SYSTEM

K141109 · Leica Biosystems Imaging, Inc. · Pathology

Jul 2014

Decision

91d

Days

—

Risk

About This 510(k) Submission

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 review panel.

Submission Details

510(k) Number	K141109 FDA.gov
FDA Decision	Cleared 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