Cleared Traditional

VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)

K121033 · Ventana Medical Systems, Inc. · Pathology
Sep 2013
Decision
519d
Days
—
Risk

About This 510(k) Submission

K121033 is an FDA 510(k) clearance for the VIRTUOSO SYSTEM FOR IHC KI-67 (30-9), submitted by Ventana Medical Systems, Inc. (Los Angeles, US). The FDA issued a Cleared decision on September 6, 2013, 519 days after receiving the submission on April 5, 2012. This device falls under the Pathology review panel.

Submission Details

510(k) Number K121033 FDA.gov
FDA Decision Cleared SESE
Date Received April 05, 2012
Decision Date September 06, 2013
Days to Decision 519 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

Product Code NOT
Device Class —

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