BD FOCALPOINT GS IMAGING SYSTEM
FDA premarket approval P950009/S010 · decided 2010-03-15
Approval details
- PMA number
- P950009
- Supplement
- S010
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BD FOCALPOINT GS IMAGING SYSTEM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Applicant
- Bd Diagnostics
- Date received
- 2009-06-25
- Decision date
- 2010-03-15
- Days to decision
- 263 days
- Decision code
- APPR
- Product code
- MNM
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT TRIPATH IMAGING, INC. IN MELBANE, NORTH CAROLINA.
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