BD FOCALPOINT SLIDE PROFILER
FDA premarket approval P950009/S014 · decided 2012-03-09
Approval details
- PMA number
- P950009
- Supplement
- S014
- 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
- 2012-01-17
- Decision date
- 2012-03-09
- Days to decision
- 52 days
- Decision code
- APPR
- Product code
- MNM
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR UPDATING THE FIELD OF VIEW (FOV) BOARD FROM VERSION 2 TO VERSION 3.
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