Cleared Traditional

K080910 - PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS (FDA 510(k) Clearance)

K080910 · Bioimagene, Inc. · Pathology device
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Feb 2009
Decision
309d
Days
-
Risk

K080910 is an FDA 510(k) clearance for the PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS.

Submitted by Bioimagene, Inc. (Cupertino, US). The FDA issued a Cleared decision on February 4, 2009 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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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Submission Details

510(k) Number K080910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2008
Decision Date February 04, 2009
Days to Decision 309 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
232d slower than avg
Panel avg: 77d · This submission: 309d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NOT
Device Class -