Home / 510(k) Clearances / K130861

510(k) K130861

MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK) by Dako North America, Inc. — Product Code MXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2013
Date Received
March 28, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunohistochemistry Assay, Antibody, Progesterone Receptor
Device Class
Class II
Regulation Number
864.1860
Review Panel
PA
Submission Type

Other clearances by Dako North America, Inc.

  • K160922 — FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (May 3, 2016)
  • K120663 — MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI (February 12, 2013)
  • K081286 — MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M (May 8, 2009)

Other clearances for product code MXZ

  • K193393 — BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid (March 6, 2020)
  • K183102 — BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra (December 7, 2018)
  • K170005 — FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to (December 21, 2017)
  • K171753 — BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra (July 21, 2017)
  • K160922 — FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (May 3, 2016)
  • K103818 — CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY (November 16, 2011)
  • K062615 — VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16 (January 29, 2007)
  • K060462 — NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP (April 24, 2006)
  • K042884 — DAKOCYTOMATION ER/PR PHARMDX KIT (February 15, 2005)
  • K012960 — BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR (March 8, 2002)