PMA P970018S029
- Device
- BD PREPSTAIN SYSTEM
- Applicant
- Bd Diagnostic Systems
- PMA number
- P970018
- Supplement
- S029
- Product code
- MKQ
- Decision date
- 2013-12-13
- Generic name
- Processor, cervical cytology slide, automated
- Approval order statement
- REMOVAL OF AN IN-PROCESS QUALITY CONTROL (QC) TEST AND A FINAL RELEASE TEST ASSOCIATED WITH THE MANUFACTURE OF BD DENSITY REAGENT.
Current openFDA PMA Record#
- Device
- BD PREPSTAIN SYSTEM
- Applicant
- Bd Diagnostic Systems
- PMA number
- P970018
- Supplement
- S029
- Product code
- MKQ
- Generic name
- Processor, cervical cytology slide, automated
- Decision date
- 2013-12-13
- Decision code
- OK30
- Date received
- 2013-11-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REMOVAL OF AN IN-PROCESS QUALITY CONTROL (QC) TEST AND A FINAL RELEASE TEST ASSOCIATED WITH THE MANUFACTURE OF BD DENSITY REAGENT.