PMA P970018S040

Device
BD PrepMate
Applicant
Bd Diagnostic Systems
PMA number
P970018
Supplement
S040
Product code
MKQ
Decision date
2023-12-28
Classification
Pathology
Generic name
Processor, cervical cytology slide, automated
Approval order statement
Manufacturing site change for BD PrepMate Automated Accessory.

Current openFDA PMA Record#

Device
BD PrepMate
Applicant
Bd Diagnostic Systems
PMA number
P970018
Supplement
S040
Product code
MKQ
Generic name
Processor, cervical cytology slide, automated
Decision date
2023-12-28
Decision code
APPR
Date received
2023-09-01
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Manufacturing site change for BD PrepMate Automated Accessory.