BD TOTALYS SLIDEPREP
FDA premarket approval P970018/S030 · decided 2016-02-12
Approval details
- PMA number
- P970018
- Supplement
- S030
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BD TOTALYS SLIDEPREP
- Generic name
- Processor, cervical cytology slide, automated
- Applicant
- Bd Diagnostic Systems
- Date received
- 2014-11-03
- Decision date
- 2016-02-12
- Days to decision
- 466 days
- Decision code
- APPR
- Product code
- MKQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Durham, NC
- Statement
- Approval for the BD Totalys SlidePrep (and use of the BD FocalPoint Slide Profiler with slides prepared by the BD Totalys SlidePrep). The devices, as modified, will be marketed under the trade names BD Totalys SlidePrep and BD FocalPoint Slide Profiler, respectively.
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| 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 |