Atlas FDA

Roche Digital Pathology Dx (VENTANA DP 200)

FDA 510(k) clearance K232879 · decided 2024-06-14

Clearance details

K-number
K232879
Device name
Roche Digital Pathology Dx (VENTANA DP 200)
Applicant
Ventana Medical Systems, Inc.
Decision
Substantially Equivalent
Date received
2023-09-18
Decision date
2024-06-14
Days to decision
270 days
Clearance type
Traditional
Product code
PSY
Device class
2
Regulation number
864.3700
Medical specialty
Pathology
Advisory committee
Pathology
Location
Tucson, AZ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
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PMA approvals by this applicant

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PATHWAY anti- HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S059)Ventana Medical Systems, Inc.2025-12-15
HER2 Dual ISH DNA Probe Cocktail (P190031/S014)Ventana Medical Systems, Inc.2025-12-15
CINtec PLUS Cytology (P190024/S015)Ventana Medical Systems, Inc.2025-09-04
CINtec PLUS Cytology (P190024/S014)Ventana Medical Systems, Inc.2025-07-31
VENTANA CLDN18 (43-14A) RxDx Assay (P230018/S001)Ventana Medical Systems, Inc.2025-06-20
PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S057)Ventana Medical Systems, Inc.2025-06-20
VENTANA ALK (D5F3) CDX ASSAY (P140025/S025)Ventana Medical Systems, Inc.2025-06-20
VENTANA PD-L1 (SP263) ASSAY (P160046/S020)Ventana Medical Systems, Inc.2025-06-20