Reader, Cervical Cytology Slide, Automated

FDA product code MNM · Class III (high risk) · Pathology

0510(k) clearances

3PMA approvals

1recalls

PMA approvals

P020002 Thinprep (R) Imaging System · Hologic, Inc. · 06/06/2003
P940029 Papnet (R) Testing System · Bd Diagnostics · 11/08/1995
P950009 Autopap(R) 300 QC Automatic Pap Screener/Qc System · Bd Diagnostics · 09/29/1995

Recall	Product	Firm	Initiated
Z-0081-2019 Class III	BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398…The device may not function at the lower end (<15 deg. C) of the labeled operating temperatures. The…	Becton Dickinson & Co.	09/21/2018Terminated