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510(k) K042884

DAKOCYTOMATION ER/PR PHARMDX KIT by Dakocytomation California, Inc. — Product Code MXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2005
Date Received
October 19, 2004
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 Dakocytomation California, Inc.

  • K060423 — CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES (August 15, 2006)

Other clearances for product code MXZ

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  • 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)
  • K130861 — MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE ( (December 9, 2013)
  • 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)
  • K012960 — BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR (March 8, 2002)