BD FOCAL POINT SLIDE PROFILER
FDA premarket approval P950009/S017 · decided 2014-02-26
Approval details
- PMA number
- P950009
- Supplement
- S017
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BD FOCAL POINT SLIDE PROFILER
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Applicant
- Bd Diagnostics
- Date received
- 2013-12-02
- Decision date
- 2014-02-26
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- MNM
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR REPLACEMENT OF THE CURRENT SCAN CONTROLLER BOARD (SCB) UTILIZED IN THE BD FOCALPOINT¿ SLIDE PROFILER WITH DIGITAL IMAGE SYSTEM CONFIGURATION.
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