BD FOCALPOINT SLIDE PROFILER
FDA premarket approval P950009/S019 · decided 2015-07-23
Approval details
- PMA number
- P950009
- Supplement
- S019
- 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
- 2015-04-24
- Decision date
- 2015-07-23
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MNM
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR A REPLACEMENT WORKSTATION AND SOFTWARE MODIFICATIONS FOR THE BD FOCALPOINT SLIDE PROFILER.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.