VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)— 510(k) K984567
Substantially EquivalentVentana, Inc.
FDA 510(k) clearance K984567 for VENTANA ER PRIMARY ANTIBODY (CLONE 6F11), Substantially Equivalent on 1999-08-12. Applicant: Ventana, Inc.. Device class: 2.
Clearance details
- Applicant
- Ventana, 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
Recent devices under product code MYA
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- K120663 — MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI
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Data sourced from openFDA. This site is unofficial and independent of the FDA.