Cleared Traditional

ARIOL HER-2/NEU IHC

K031715 · Applied Imaging Corp. · Pathology
Jan 2004
Decision
220d
Days
—
Risk

About This 510(k) Submission

K031715 is an FDA 510(k) clearance for the ARIOL HER-2/NEU IHC, submitted by Applied Imaging Corp. (Santa Clara, US). The FDA issued a Cleared decision on January 8, 2004, 220 days after receiving the submission on June 2, 2003. This device falls under the Pathology review panel.

Submission Details

510(k) Number K031715 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2003
Decision Date January 08, 2004
Days to Decision 220 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Statement

Device Classification

Product Code NOT
Device Class —

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