Product code MYA— Hematology
VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
- Classification name
- Immunohistochemistry Antibody Assay, Estrogen Receptor
- Device class
- Class 2
- Regulation
- 21 CFR 864.1860
- Advisory panel
- Hematology
- Total cleared
- 12
- First cleared
- Most recent
Market context for product code MYA
FDA has cleared devices under product code MYA between 1999 and 2018, filed by 11 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2018
- 2017
- 2014
- 2013
- 2012
- 2009
- 2006
- 2002
- 2000
- 1999
Top applicants under product code MYA
Recent clearances under product code MYA
- K183100 — Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra
- K170028 — FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)
- K122556 — VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
- K120663 — MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI
- K110215 — CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY
- K081286 — MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634
- K061360 — NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1)
- K060227 — VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
- K012138 — MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)
- K013148 — BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)
- K993957 — DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR
- K984567 — VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)
Data sourced from openFDA. This site is unofficial and independent of the FDA.