BD FOCALPOINT SLIDE PROFILER
FDA premarket approval P950009/S018 · decided 2016-02-12
Approval details
- PMA number
- P950009
- Supplement
- S018
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BD FOCALPOINT SLIDE PROFILER
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Applicant
- Bd Diagnostics
- Date received
- 2014-11-12
- Decision date
- 2016-02-12
- Days to decision
- 457 days
- Decision code
- APPR
- Product code
- MNM
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Durham, NC
- Statement
- Approval for the BD FocalPoint Slide Profiler with slides prepared by the BD Totalys SlidePrep.
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