Cleared Traditional

VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)

K122556 · Leica Biosystems Newcastle, Ltd. · Pathology
May 2014
Decision
635d
Days
Class 2
Risk

About This 510(k) Submission

K122556 is an FDA 510(k) clearance for the VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11), a Immunohistochemistry Antibody Assay, Estrogen Receptor (Class II — Special Controls, product code MYA), submitted by Leica Biosystems Newcastle, Ltd. (Richmond, US). The FDA issued a Cleared decision on May 19, 2014, 635 days after receiving the submission on August 22, 2012. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1860.

Submission Details

510(k) Number K122556 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2012
Decision Date May 19, 2014
Days to Decision 635 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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