Cleared Traditional

MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634

K081286 · Dako North America, Inc. · Pathology
May 2009
Decision
366d
Days
Class 2
Risk

About This 510(k) Submission

K081286 is an FDA 510(k) clearance for the MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634, a Immunohistochemistry Antibody Assay, Estrogen Receptor (Class II — Special Controls, product code MYA), submitted by Dako North America, Inc. (Carpinteria, US). The FDA issued a Cleared decision on May 8, 2009, 366 days after receiving the submission on May 7, 2008. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1860.

Submission Details

510(k) Number K081286 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 2008
Decision Date May 08, 2009
Days to Decision 366 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

Product Code MYA — Immunohistochemistry Antibody Assay, Estrogen Receptor
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.1860

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