FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Processor, Cervical Cytology Slide, Automated
PMA: P970018
·
Supplement: S012
·
Decision May 9, 2007
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- Processor, Cervical Cytology Slide, Automated
- Trade Name
- PREPSTAIN SYSTEM
- PMA Number
- P970018
- Supplement Number
- S012
- 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
- May 9, 2007
- Date Received
- April 19, 2007
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR LABELING CHANGES FOR EXTENSION OF THE ANTIMICROBIAL EFFECTIVENESS OF THE SUREPATH PRESERVATIVE FLUID TO 14 DAYS FOR E. COLI, P. AERUGINOSA, S. AUREUS, C. ALBICANS, AND A. NIGER AND 28 DAYS FOR M. TUBERCULOSIS.
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 |