PMA P970018S016

Device: PREPSTAIN SYSTEM
Applicant: Bd Diagnostic Systems
PMA number: P970018
Supplement: S016
Product code: MKQ
Decision date: 2009-07-02
Generic name: Processor, cervical cytology slide, automated
Approval order statement: CHANGES TO THE METHOD OF MANUFACTURING FROM A MANUAL PROCESS TO AN AUTOMATED PROCESS TO REDUCE PRODUCTION COSTS AND IMPROVE CONTROL OF THE MANUFACTURING PROCESS.

Current openFDA PMA Record#

Device: PREPSTAIN SYSTEM
Applicant: Bd Diagnostic Systems
PMA number: P970018
Supplement: S016
Product code: MKQ
Generic name: Processor, cervical cytology slide, automated
Decision date: 2009-07-02
Decision code: OK30
Date received: 2009-06-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGES TO THE METHOD OF MANUFACTURING FROM A MANUAL PROCESS TO AN AUTOMATED PROCESS TO REDUCE PRODUCTION COSTS AND IMPROVE CONTROL OF THE MANUFACTURING PROCESS.