BD BACTEC FXI Culture System
FDA 510(k) clearance K260213 · decided 2026-05-28
Clearance details
- K-number
- K260213
- Device name
- BD BACTEC FXI Culture System
- Applicant
- BD Diagnostic Systems
- Decision
- Substantially Equivalent
- Date received
- 2026-01-23
- Decision date
- 2026-05-28
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- MDB
- Device class
- 1
- Regulation number
- 866.2560
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Sparks, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BD PrepStain System, BD Totalys MultiProcessor, BD Totalys SlidePre, BD SurePath Liquid-based Pap Test (P970018/S041) | Bd Diagnostic Systems | 2024-09-06 |
| BD PrepMate (P970018/S040) | Bd Diagnostic Systems | 2023-12-28 |
| BD Totalys MultiProcessor (P970018/S039) | Bd Diagnostic Systems | 2021-12-21 |
| BD PrepStain System (P970018/S038) | Bd Diagnostic Systems | 2021-05-20 |
| BD PrepStain System (P970018/S037) | Bd Diagnostic Systems | 2021-02-16 |
| BD PrepStain System (P970018/S036) | Bd Diagnostic Systems | 2018-06-21 |
| BD Totalys SlidePrep (P970018/S035) | Bd Diagnostic Systems | 2018-01-12 |
| BD SUREPATH COLLECTION VIAL (P970018/S033) | Bd Diagnostic Systems | 2016-12-02 |