PREPSTAIN SYSTEM/PREPMATE
FDA premarket approval P970018/S024 · decided 2011-09-21
Approval details
- PMA number
- P970018
- Supplement
- S024
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PREPSTAIN SYSTEM/PREPMATE
- Generic name
- Processor, cervical cytology slide, automated
- Applicant
- Bd Diagnostic Systems
- Date received
- 2011-08-24
- Decision date
- 2011-09-21
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MKQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR UPDATING THE PRODUCT LABELING AND THE PREPMATE OPERATOR MANUAL. REQUESTED CHANGES TO THE PRODUCT LABELING INCLUDE UPDATING THE MET MARK, UPDATING THE MANUFACTURING ADDRESS AND EC AUTHORIZED REPRESENTATIVE NAME AND ADDRESS, ADDING CE MARK, AND ADDING BD BRANDING TO SERIAL NUMBER LABELS AND BOX LABELS. CHANGES TO THE OPERATOR MANUAL INCLUDE EDITORIAL CHANGES INTENDED TO CLARIFY AND/OR CORRECT SOME EXISTING TEXT, WHICH INCLUDED UPDATING THE COMPANY AND INSTRUMENT NAME AND BRANDING.
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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 |