Cleared Traditional

K031715 - ARIOL HER-2/NEU IHC

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.

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FDA 510(k) Submission Details - K031715

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.

NOT Device Classification - Class ,

Product Code NOT
Device Class -