Home / 510(k) Clearances / K993957

510(k) K993957

DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR by Dako Corp. — Product Code MYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2000
Date Received
November 22, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Dako Corp.

  • K041627 — CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR (September 3, 2004)
  • K032692 — DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 (January 22, 2004)
  • K020023 — DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY (February 28, 2002)
  • K991402 — DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T (June 21, 1999)
  • K991454 — MOUSE IGG1 NEGATIVE CONTROLS (June 21, 1999)
  • K980635 — DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37 (July 22, 1998)
  • K971905 — DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLON (December 12, 1997)
  • K965022 — MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMA (November 6, 1997)
  • K964974 — MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RP (June 24, 1997)
  • K961701 — MOUSE ANTI-HUMAN CD3, T-CELL, FITC AND CD4, T-CELL, (HELPER/INDUCER) RPE (July 16, 1996)

Other clearances for product code MYA

  • K183100 — Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Re (December 7, 2018)
  • K170028 — FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmi (December 21, 2017)
  • K122556 — VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) (May 19, 2014)
  • K120663 — MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI (February 12, 2013)
  • K110215 — CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY (December 17, 2012)
  • K081286 — MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M (May 8, 2009)
  • K061360 — NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1) (June 27, 2006)
  • K060227 — VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) (May 25, 2006)
  • K012138 — MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) (September 30, 2002)
  • K013148 — BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) (February 28, 2002)