PREPSTAIN INSTRUMENT
FDA premarket approval P970018/S019 · decided 2010-03-11
Approval details
- PMA number
- P970018
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PREPSTAIN INSTRUMENT
- Generic name
- Processor, cervical cytology slide, automated
- Applicant
- Bd Diagnostic Systems
- Date received
- 2009-10-22
- Decision date
- 2010-03-11
- Days to decision
- 140 days
- Decision code
- APPR
- Product code
- MKQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL TO CHANGE THE DESIGN OF THE DITI (DISPOSABLE TIP) CONE OF THE PREPSTAIN INSTRUMENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BD PREPSTAIN¿ SYSTEM (FORMERLY AUTOCYTE®PREP SYSTEM) AND IS INDICATED FOR LIQUID-BASED THIN LAYER CELL PREPARATION PROCESS. THE PREPSTAIN SYSTEM PRODUCES SUREPATH SLIDES (FORMERLYAUTOCYTE®PREP SLIDES) THAT ARE INTENDED AS REPLACEMENT FOR CONVENTIONAL GYNECOLOGIC PAPSMEARS. SUREPATH SLIDES ARE INTENDED FOR USE IN THE SCREENING AND DETECTION OF
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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 |