CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY— 510(k) K103818
Substantially EquivalentVentana Medical Sytems, Inc.
FDA 510(k) clearance K103818 for CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY, Substantially Equivalent on 2011-11-16. Applicant: Ventana Medical Sytems, Inc.. Device class: 2.
Clearance details
- Applicant
- Ventana Medical Sytems, Inc.
- Product code
- Code MXZ
- Device class
- Class 2
- Regulation
- 21 CFR 864.1860
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tucson, AZ, US
Recent devices under product code MXZ
view all- K193393 — BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).
- K183102 — BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody
- K170005 — FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)
- K171753 — BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16
- K160922 — FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link) +1 more
Recalls naming K103818
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103818.
Data sourced from openFDA. This site is unofficial and independent of the FDA.