PMA P970018S014

Device: PREPSTAIN SYSTEM
Applicant: Bd Diagnostic Systems
PMA number: P970018
Supplement: S014
Product code: MKQ
Decision date: 2008-11-07
Generic name: Processor, cervical cytology slide, automated
Approval order statement: APPROVAL FOR A DESIGN CHANGE TO IMPROVE SHIELDING OF THE HORIZONTAL INTERFACE BOARD AND ACCOMPANYING LABELING CHANGES TO CLARIFY PRECAUTIONS AND INSTRUCTIONS.

Current openFDA PMA Record#

Device: PREPSTAIN SYSTEM
Applicant: Bd Diagnostic Systems
PMA number: P970018
Supplement: S014
Product code: MKQ
Generic name: Processor, cervical cytology slide, automated
Decision date: 2008-11-07
Decision code: APPR
Date received: 2008-07-21
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A DESIGN CHANGE TO IMPROVE SHIELDING OF THE HORIZONTAL INTERFACE BOARD AND ACCOMPANYING LABELING CHANGES TO CLARIFY PRECAUTIONS AND INSTRUCTIONS.