VENTANA CD30 (Ber-H2) RxDx Assay— 510(k) K172471
Substantially EquivalentVentana Medical Systems, Inc.
FDA 510(k) clearance K172471 for VENTANA CD30 (Ber-H2) RxDx Assay, Substantially Equivalent on 2018-05-08. Applicant: Ventana Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Ventana Medical Systems, Inc.
- Product code
- Code DEH
- Device class
- Class 2
- Regulation
- 21 CFR 866.5550
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tucson, AZ, US
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