AUTOCYTE PREP SYSTEM
FDA premarket approval P970018/S002 · decided 2001-05-25
Approval details
- PMA number
- P970018
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AUTOCYTE PREP SYSTEM
- Generic name
- Processor, cervical cytology slide, automated
- Applicant
- Bd Diagnostic Systems
- Date received
- 2000-12-01
- Decision date
- 2001-05-25
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- MKQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR THE ADDITION OF THE PREPMATE ACCESSORY (PREPMATE METHOD), WHICH AUTOMATES THE INITIAL MANUAL STEPS OF THE AUTOCYTE PREP LABORATORY PROCESS. THE PREPMATE AUTOMATICALLY MIXES AND REMOVES THE SPECIMEN FROM THE GYN PRESERVATIVE VIALS, AND LAYERS THE SPECIMEN ONTO CYTORICH DENSITY REAGENT IN A TEST TUBE, AND FOR THE ADDITION OF THE MANUAL METHOD, IN WHICH, RATHER THAN USING THE AUTOCYTE PREP SYSTEM FOR CELL SUSPENSION AND SLIDE STAINING, THE CELL SUSPENSION IS MANUALLY LAYERED ONTO THE S
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BD BACTEC FXI Culture System (K260213) | BD Diagnostic Systems | 2026-05-28 |
| PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP) (K032518) | Bd Diagnostic Systems | 2003-09-15 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML (K032153) | Bd Diagnostic Systems | 2003-09-11 |
| PASCO MIC AND MIC/ID PANELS (K032259) | Bd Diagnostic Systems | 2003-08-19 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML (K031429) | Bd Diagnostic Systems | 2003-06-06 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML (K030091) | Bd Diagnostic Systems | 2003-02-28 |