Cleared Traditional

VIRTUSO SYSTEM FOR IHC (DO-7)

K121350 · Ventana Medical Systems, Inc. · Pathology
Jun 2012
Decision
28d
Days
—
Risk

About This 510(k) Submission

K121350 is an FDA 510(k) clearance for the VIRTUSO SYSTEM FOR IHC (DO-7), submitted by Ventana Medical Systems, Inc. (Los Angeles, US). The FDA issued a Cleared decision on June 1, 2012, 28 days after receiving the submission on May 4, 2012. This device falls under the Pathology review panel.

Submission Details

510(k) Number K121350 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 2012
Decision Date June 01, 2012
Days to Decision 28 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

Product Code NOT
Device Class —

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