BD FOCALPOINT SLIDE PROFILER
FDA premarket approval P950009/S015 · decided 2013-09-13
Approval details
- PMA number
- P950009
- Supplement
- S015
- 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
- 2012-03-28
- Decision date
- 2013-09-13
- Days to decision
- 534 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 THE NEW DIGITAL PRIMARYCAMERA.
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