510(k) K915796 ยท MDB System, Blood Culturing
BACTEC 9240 SYSTEM
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Roswell GA, US |
| Decision | Substantially Equivalent, Apr 22, 1992 |
| Received | Dec 24, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915796
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2025 | Becton Dickinson & Co. BD BACTEC Blood Culture System, labeled as the following:
1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509.
2. Instrument Top Remanufactured Bactec Fx, Catalog Number: 441676.
3 Open, Classified |
MDB | None listed |
| Dec 3, 2024 | Becton Dickinson & Co. BD BACTEC FX, Instrument Top, Packaged
Version or Model: 441385
Catalog Number: 441385 Open, Classified |
MDB | None listed |
| Dec 3, 2024 | Becton Dickinson & Co. BD BACTEC FX40 Instrument
Version or Model: 442296
Catalog Number: 442296 Open, Classified |
MDB | None listed |
| Dec 3, 2024 | Becton Dickinson & Co. BACTEC 9240 System
Version or Model: 445475
Catalog Number: 445475 Open, Classified |
MDB | None listed |
| Jan 30, 2014 | Becton Dickinson & Co. BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386, available as a single or a stack configuration; Manufactured by BD Diagnostic Systems, 7 Loveton C Terminated |
MDB | None listed |
| Jan 30, 2014 | Becton Dickinson & Co. BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152.
The instrument is designed for the rapid detection of bacteria and fungi Terminated |
MDB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.