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510(k) K012960

BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR by Biogenex Laboratories — Product Code MXZ

K012960 is an FDA 510(k) premarket notification submitted by Biogenex Laboratories for the device "BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR". The FDA issued a decision of Substantially Equivalent on March 8, 2002. The device falls under product code MXZ (Immunohistochemistry Assay, Antibody, Progesterone Receptor), a Class II device regulated under 21 CFR 864.1860. Biogenex Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2002
Date Received
September 4, 2001
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 Biogenex Laboratories

  • K013148 — BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) (February 28, 2002)
  • K925189 — PREGNAGEN 1-STEP PREGNANCY TEST (January 6, 1993)
  • K902208 — MODIFIED OVUGEN (July 17, 1990)
  • K884880 — PREGNAGEN(TM) (January 13, 1989)
  • K882002 — PREGNAGEN(TM) (September 9, 1988)
  • K873534 — OVUGEN SURETEST (November 23, 1987)
  • K831221 — RIAGEN B-HCG RIA KIT (June 2, 1983)
  • K821657 — RIAGEN B-HCG RIA (July 13, 1982)
  • K821234 — RIAGEN B-HCG RIA (May 21, 1982)
  • K820724 — FLUOROGEN PAP FIA (April 14, 1982)

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)
  • 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)
  • K042884 — DAKOCYTOMATION ER/PR PHARMDX KIT (February 15, 2005)

FDA data resources