PMA P950009S001
- Device
- AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM
- Applicant
- Bd Diagnostics
- PMA number
- P950009
- Supplement
- S001
- Product code
- MNM
- Decision date
- 1996-04-25
- Classification
- Reader, Cervical Cytology Slide, Automated
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Approval order statement
- APPROVAL FOR CHANGES MADE TO THE MANUAL TO IMPROVE HOW THE REPORT FORMS WILL LOOK, FOR CLARITY.
Current openFDA PMA Record#
- Device
- AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM
- Applicant
- Bd Diagnostics
- PMA number
- P950009
- Supplement
- S001
- Product code
- MNM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Decision date
- 1996-04-25
- Decision code
- APPR
- Date received
- 1995-11-06
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES MADE TO THE MANUAL TO IMPROVE HOW THE REPORT FORMS WILL LOOK, FOR CLARITY.