Cleared Traditional

CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY

K110215 · Ventana Medical Systems, Inc. · Pathology
Dec 2012
Decision
719d
Days
Class 2
Risk

About This 510(k) Submission

K110215 is an FDA 510(k) clearance for the CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY, a Immunohistochemistry Antibody Assay, Estrogen Receptor (Class II — Special Controls, product code MYA), submitted by Ventana Medical Systems, Inc. (Tucso, US). The FDA issued a Cleared decision on December 17, 2012, 719 days after receiving the submission on December 29, 2010. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1860.

Submission Details

510(k) Number K110215 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 2010
Decision Date December 17, 2012
Days to Decision 719 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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