PMA P970018S021

Device
PREPSTAIN SYSTEM
Applicant
Bd Diagnostic Systems
PMA number
P970018
Supplement
S021
Product code
MKQ
Decision date
2010-06-30
Generic name
Processor, cervical cytology slide, automated
Approval order statement
APPROVAL FOR CHANGES MADE TO THE PREPSTAIN SOFTWARE TO REFLECT CUSTOMER PREFERENCE FOR ¿PREP ONLY¿ PROCESSING.

Current openFDA PMA Record#

Device
PREPSTAIN SYSTEM
Applicant
Bd Diagnostic Systems
PMA number
P970018
Supplement
S021
Product code
MKQ
Generic name
Processor, cervical cytology slide, automated
Decision date
2010-06-30
Decision code
APPR
Date received
2010-04-05
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR CHANGES MADE TO THE PREPSTAIN SOFTWARE TO REFLECT CUSTOMER PREFERENCE FOR ¿PREP ONLY¿ PROCESSING.