PMA P970018

Device: BD PrepStain System, BD Totalys MultiProcessor, BD Totalys SlidePre, BD SurePath Liquid-based Pap Test
Applicant: Bd Diagnostic Systems
PMA number: P970018
Supplement: S039
Product code: MKQ
Decision date: 2024-09-06
Generic name: Processor, cervical cytology slide, automated
Approval order statement: Requested approval for specific labeling change that removes language indicating that user training for the PrepStain System must be provided by BD but maintains that laboratory personnel must be qualified to prepare or evaluate cytology slides prepared using the respective instrumentation.

Current openFDA PMA Record#

Device: BD PrepStain System, BD Totalys MultiProcessor, BD Totalys SlidePre, BD SurePath Liquid-based Pap Test
Applicant: Bd Diagnostic Systems
PMA number: P970018
Supplement: S041
Product code: MKQ
Generic name: Processor, cervical cytology slide, automated
Decision date: 2024-09-06
Decision code: APPR
Date received: 2024-08-13
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Requested approval for specific labeling change that removes language indicating that user training for the PrepStain System must be provided by BD but maintains that laboratory personnel must be qualified to prepare or evaluate cytology slides prepared using the respective instrumentation.