AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM
FDA premarket approval P950009/S001 · decided 1996-04-25
Approval details
- PMA number
- P950009
- Supplement
- S001
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Applicant
- Bd Diagnostics
- Date received
- 1995-11-06
- Decision date
- 1996-04-25
- Days to decision
- 171 days
- Decision code
- APPR
- Product code
- MNM
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR CHANGES MADE TO THE MANUAL TO IMPROVE HOW THE REPORT FORMS WILL LOOK, FOR CLARITY.
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