Cleared Traditional

MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)

K130861 · Dako North America, Inc. · Pathology
Dec 2013
Decision
256d
Days
Class 2
Risk

About This 510(k) Submission

K130861 is an FDA 510(k) clearance for the MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK), a Immunohistochemistry Assay, Antibody, Progesterone Receptor (Class II — Special Controls, product code MXZ), submitted by Dako North America, Inc. (Carpinteria, US). The FDA issued a Cleared decision on December 9, 2013, 256 days after receiving the submission on March 28, 2013. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1860.

Submission Details

510(k) Number K130861 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2013
Decision Date December 09, 2013
Days to Decision 256 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

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

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