BD FOCALPOINT SLIDE PROFILER
FDA premarket approval P950009/S011 · decided 2010-01-08
Approval details
- PMA number
- P950009
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BD FOCALPOINT SLIDE PROFILER
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Applicant
- Bd Diagnostics
- Date received
- 2009-12-10
- Decision date
- 2010-01-08
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MNM
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Durham, NC
- Statement
- NEW VENDOR OF A COMPONENT PROGRAMMED TO CONTROL DIFFERENT ASPECTS OF THE IMAGE PROCESSING.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.