CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY— 510(k) K110215
Substantially EquivalentVentana Medical Systems, Inc.
FDA 510(k) clearance K110215 for CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY, Substantially Equivalent on 2012-12-17. Applicant: Ventana Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Ventana Medical Systems, Inc.
- Product code
- Code MYA
- 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
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More clearances from Ventana Medical Systems, Inc.
view allRecalls naming K110215
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 K110215.
Data sourced from openFDA. This site is unofficial and independent of the FDA.