THINPREP(R) PROCESSOR, MODEL TP 2000
Device Facts
| Record ID | P950039 |
|---|---|
| Device Name | THINPREP(R) PROCESSOR, MODEL TP 2000 |
| Applicant | Hologic, Inc. |
| Product Code | MKQ · Pathology |
| Decision Date | May 20, 1996 |
| Decision | APPR |
| Device Class | Class 3 |
Regulatory Classification
Identification
It is a system that is used to collect and prepare cervical cytology specimens for Pap stain-based screening for cervical cancer. The specimens are collected and rinsed into a liquid preservative fluid from which they are then automatically filtered and deposited in a thin-layer on a glass microscope slide. They are stained and screened by a cytotechnologist and cytopathologist.
