AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM is an AI-enabled medical device from BD DIAGNOSTICS, listed by FDA (PMA, P950009) with a decision date of 1995-09-29. Review panel: Pathology.
| FDA submission number | P950009 |
|---|---|
| Pathway | PMA |
| Company | BD DIAGNOSTICS |
| Review panel (specialty) | Pathology |
| FDA decision date | 1995-09-29 |
| Product code | NMN |
| Classification | Reader, Cervical Cytology Slide, Automated |
| Device class | 3 |
| Review time (calendar days) | 217 |
Official FDA database record · FDA AI-enabled device list
All Pathology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.