MKQ · Processor, Cervical Cytology Slide, Automated
· Class 3
Overview
| Product Code | MKQ |
|---|---|
| Device Name | Processor, Cervical Cytology Slide, Automated |
| Device Class | Class 3 |
| Review Panel |
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.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P040052 | MONOPREP PAP TEST | Hologic, Inc. | Mar 3, 2006 | APWD |
| P970018 | BD PREPSTAIN SYSTEM | Bd Diagnostic Systems | Jun 17, 1999 | APPR |
| P950039 | THINPREP(R) PROCESSOR, MODEL TP 2000 | Hologic, Inc. | May 20, 1996 | APPR |
Top Applicants
- Hologic, Inc. — 2 clearances
- Bd Diagnostic Systems — 1 clearance
