AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM
FDA premarket approval P950009/S020 · decided 2016-04-19
Approval details
- PMA number
- P950009
- Supplement
- S020
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Applicant
- Bd Diagnostics
- Date received
- 2016-03-07
- Decision date
- 2016-04-19
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- MNM
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Durham, NC
- Statement
- Approval for a manufacturing site located at BD Diagnostics, 7 Loveton Circle, Sparks, MD 21152.
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