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PMA P970018S030

Device
BD TOTALYS SLIDEPREP
Applicant
Bd Diagnostic Systems
PMA number
P970018
Supplement
S030
Product code
MKQ
Decision date
2016-02-12
Generic name
Processor, cervical cytology slide, automated
Approval order statement
Approval for the BD Totalys™ SlidePrep (and use of the BD FocalPoint™ Slide Profiler with slides prepared by the BD Totalys™ SlidePrep). The devices, as modified, will be marketed under the trade names BD Totalys™ SlidePrep and BD FocalPoint™ Slide Profiler, respectively.

Current openFDA PMA Record#

Device
BD TOTALYS SLIDEPREP
Applicant
Bd Diagnostic Systems
PMA number
P970018
Supplement
S030
Product code
MKQ
Generic name
Processor, cervical cytology slide, automated
Decision date
2016-02-12
Decision code
APPR
Date received
2014-11-03
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the BD Totalys™ SlidePrep (and use of the BD FocalPoint™ Slide Profiler with slides prepared by the BD Totalys™ SlidePrep). The devices, as modified, will be marketed under the trade names BD Totalys™ SlidePrep and BD FocalPoint™ Slide Profiler, respectively.