Cleared Traditional

K031715 - ARIOL HER-2/NEU IHC (FDA 510(k) Clearance)

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

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 after a review of 220 days - an extended review cycle.

This device falls under the Pathology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Applied Imaging Corp. devices

Submission Details

510(k) Number K031715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 77d · This submission: 220d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NOT
Device Class -