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510(k) K060462

NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2) by Lab Vision Corp. — Product Code MXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2006
Date Received
February 22, 2006
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 Lab Vision Corp.

  • K061360 — NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1) (June 27, 2006)

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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)
  • K042884 — DAKOCYTOMATION ER/PR PHARMDX KIT (February 15, 2005)
  • K012960 — BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR (March 8, 2002)