510(k) K021582 ยท MJA Susceptibility Test Powders, Antimycobacterial
BACTEC MGIT 960 PZA KIT
| Applicant | Becton, Dickinson & CO, Sparks MD, US |
| Decision | Substantially Equivalent, Jul 13, 2002 |
| Received | May 14, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021582
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 25, 2025 | Becton Dickinson & Co. BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA). Open, Classified |
MJA | None listed |
| Aug 16, 2024 | Becton Dickinson & Co. BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA)
Catalog Number: 245128 Open, Classified |
MJA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.