Cleared Special

FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link)

K160922 · Dako North America, Inc. · Pathology
May 2016
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K160922 is an FDA 510(k) clearance for the FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX 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 May 3, 2016, 29 days after receiving the submission on April 4, 2016. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1860.

Submission Details

510(k) Number K160922 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2016
Decision Date May 03, 2016
Days to Decision 29 days
Submission Type Special
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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