Panels › Microbiology › Product code MJA · Class 2
Susceptibility Test Powders, Antimycobacterial
Regulation 866.1640
0510(k)s in 12 months (5 all time)
0recalls in 12 months (6 all time)
2recalls that name a 510(k)
Top companies in MJA
| Company | 510(k)s | Recalls |
|---|---|---|
| Becton, Dickinson & CO | 2 | 6 |
| Trek Diagnostic Systems, Inc. | 2 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 19, 2006 | K052323 | VERSATREK MYCO PZA KIT Trek Diagnostic Systems, Inc. | MJA |
| Jul 13, 2002 | K021582 | BACTEC MGIT 960 PZA KIT Becton, Dickinson & CO | MJA |
| Apr 19, 2002 | K014123 | BACTEC MGIT 960 SIRE KITS Becton, Dickinson & CO | MJA |
| Jun 6, 2001 | K003062 | BACTEC MGIT 960 SIR KITS Bd Becton Dickinson Vacutainer Systems Preanalytic | MJA |
| Jul 13, 1999 | K972772 | ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING Trek Diagnostic Systems, Inc. | MJA |
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