FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Processor, Cervical Cytology Slide, Automated
PMA: P040052
·
Supplement: S004
·
Decision Aug 31, 2007
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- Processor, Cervical Cytology Slide, Automated
- Trade Name
- MONOPREP PAP TEST
- PMA Number
- P040052
- Supplement Number
- S004
- Device Class
- FDA Class 3
- Product Code
- MKQ
- Generic Name
- Processor, cervical cytology slide, automated
- Medical Specialty
- Unknown
- Advisory Committee
- Pathology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 31, 2007
- Date Received
- July 27, 2007
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR USE OF REFLECTIVE WHITE LABEL STOCK (PN 12358) ON ALL MONOPREP VIALS, INCLUDING THE MONOPREP PAP TEST VIAL AND THE REPROCESSING VIAL.
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 |
|---|---|---|---|
| MKQ | Processor, Cervical Cytology Slide, Automated | FDA class 3 | Unknown |