510(k) K020321 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
| Applicant | Becton, Dickinson & CO, Sparks MD, US |
| Decision | Substantially Equivalent, May 23, 2002 |
| Received | Jan 15, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020321
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2025 | Becton Dickinson & Co. BD Phoenix M50 Instrument, labeled as the following:
1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers: 443624, 44362409. Open, Classified |
LON | None listed |
| Dec 3, 2024 | Becton Dickinson & Co. BD Phoenix M50 Automated Microbiology System
Version or Model: 443624
Catalog Number: 443624 Open, Classified |
LON | None listed |
| Sep 24, 2024 | Becton Dickinson & Co. BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results fo Open, Classified |
LON | None listed |
| Sep 24, 2024 | Becton Dickinson & Co. BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerob Open, Classified |
LON | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.