Cleared Traditional

MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI

K120663 · Dako North America, Inc. · Pathology
Feb 2013
Decision
344d
Days
Class 2
Risk

About This 510(k) Submission

K120663 is an FDA 510(k) clearance for the MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI, 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 February 12, 2013, 344 days after receiving the submission on March 5, 2012. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1860.

Submission Details

510(k) Number K120663 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2012
Decision Date February 12, 2013
Days to Decision 344 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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