BD FOCALPOINT SLIDE PROFILER
FDA premarket approval P950009/S013 · decided 2011-11-10
Approval details
- PMA number
- P950009
- Supplement
- S013
- Supplement type
- Real-Time Process
- 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
- 2011-09-15
- Decision date
- 2011-11-10
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- MNM
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR SOFTWARE CHANGES TO THE BD FOCALPOINT SLIDE PROFILER FROM THE CURRENT PRODUCTION VERSION APPS 3.4.1A TO APPS 3.5.0.
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