FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Reader, Cervical Cytology Slide, Automated
PMA: P950009
·
Decision Sep 29, 1995
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Reader, Cervical Cytology Slide, Automated
- Trade Name
- AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM
- PMA Number
- P950009
- Device Class
- FDA Class 3
- Product Code
- MNM
- Generic Name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Medical Specialty
- Unknown
- Advisory Committee
- Pathology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 29, 1995
- Date Received
- February 24, 1995
- Expedited Review
- N
- Docket Number
- 96M-0332
Advisory Committee Statement
APPROVAL FOR THE AUTOPAP 300 QC SYSTEM
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MNM | Reader, Cervical Cytology Slide, Automated | FDA class 3 | Unknown |