Definition: 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
| Device Type ID | 5034 |
| Device Name | Processor, Cervical Cytology Slide, Automated |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MKQ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5034 |
| Device | Processor, Cervical Cytology Slide, Automated |
| Product Code | MKQ |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 3 |
Facilities Issue | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 5 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Becton Dickinson & Co. | II | Dec-21-2016 |