PMA P190024S012

Device: CINtec PLUS Cytology
Applicant: Ventana Medical Systems, Inc.
PMA number: P190024
Supplement: S012
Product code: QKF
Decision date: 2024-01-26
Classification: Pathology
Generic name: Immunocytochemistry assay, p16/Ki-67
Approval order statement: approval for a change in expiry dating (extension to the stability from 12 months to 18 months) for Hematoxylin (PN 760-2021) and Hematoxylin II (PN 790-2208).

Current openFDA PMA Record#

Device: CINtec PLUS Cytology
Applicant: Ventana Medical Systems, Inc.
PMA number: P190024
Supplement: S012
Product code: QKF
Generic name: Immunocytochemistry assay, p16/Ki-67
Decision date: 2024-01-26
Decision code: APPR
Date received: 2023-10-30
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for a change in expiry dating (extension to the stability from 12 months to 18 months) for Hematoxylin (PN 760-2021) and Hematoxylin II (PN 790-2208).