AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM
FDA premarket approval P950009/S002 · decided 1998-05-05
Approval details
- PMA number
- P950009
- Supplement
- S002
- Supplement type
- Panel 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
- 1996-06-06
- Decision date
- 1998-05-05
- Days to decision
- 698 days
- Decision code
- APPR
- Product code
- MNM
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Durham, NC
- Statement
- The AutoPap(R) Primary Screening System is an automated cervical cytology screening device intended for use in initial screening of Papanicolaou (Pap) smear slides. The AutoPap(R) Primary Screening System identifies up to 25% of successfully processed slides as requiring no further review. The AutoPap(R) Primary Screening System also identifies as least 15% of all successfully processed slides for a second manual review. The device is to be used only on conventionally prepared Pap smear slides a
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