PREPSTAIN SYSTEM
FDA premarket approval P970018/S003 · decided 2001-11-02
Approval details
- PMA number
- P970018
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PREPSTAIN SYSTEM
- Generic name
- Processor, cervical cytology slide, automated
- Applicant
- Bd Diagnostic Systems
- Date received
- 2001-10-26
- Decision date
- 2001-11-02
- Days to decision
- 7 days
- Decision code
- APPR
- Product code
- MKQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR NAME CHANGES FROM AUTOCYTE PREP SYSTEM TO PREPSTAIN SYSTEM AND FROM CYTORICH TO SUREPATH. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES PREPSTAIN SYSTEM AND SUREPATH. THE PREPSTAIN SYSTEM AND SUREPATH IS INDICATED AS A LIQUID-BASED, THIN LAYER CELL PREPARATION PROCESS. THE PREPSTAIN SYSTEM PRODUCES SLIDES THAT ARE INTENDED AS REPLACEMENTS FOR CONVENTIONAL GYNECOLOGIC PAP SMEARS. THE PREPSTAIN SLIDES ARE INTENDED FOR USE IN THE SCREENING AND DETECTION OF CERVICAL CA
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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 |