PMA P190024S006

Device: CINtec PLUS Cytology
Applicant: Ventana Medical Systems, Inc.
PMA number: P190024
Supplement: S006
Product code: QKF
Decision date: 2022-07-21
Generic name: Immunocytochemistry assay, p16/Ki-67
Approval order statement: Approval for (i) a change in expiry dating from Hematoxylin and Hematoxylin II and (ii) implementation of a revised process for creating reference slides used in Surveillance and Stability testing of Hematoxylin and Hematoxylin II.

Current openFDA PMA Record#

Device: CINtec PLUS Cytology
Applicant: Ventana Medical Systems, Inc.
PMA number: P190024
Supplement: S006
Product code: QKF
Generic name: Immunocytochemistry assay, p16/Ki-67
Decision date: 2022-07-21
Decision code: APPR
Date received: 2022-02-16
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for (i) a change in expiry dating from Hematoxylin and Hematoxylin II and (ii) implementation of a revised process for creating reference slides used in Surveillance and Stability testing of Hematoxylin and Hematoxylin II.