Cleared Traditional

VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)

K111543 · Ventana Medical Systems, Inc. · Pathology
Oct 2011
Decision
132d
Days
—
Risk

About This 510(k) Submission

K111543 is an FDA 510(k) clearance for the VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5), submitted by Ventana Medical Systems, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on October 12, 2011, 132 days after receiving the submission on June 2, 2011. This device falls under the Pathology review panel.

Submission Details

510(k) Number K111543 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2011
Decision Date October 12, 2011
Days to Decision 132 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

Product Code NOT
Device Class —

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