MJA
5 FDA 510(k) clearances · Product code
147 daysmedian time to decision
719 days90th percentile
5clearances measured
FDA profile
- Official device name
- Susceptibility Test Powders, Antimycobacterial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Medical specialty
- Microbiology
- Adverse events (MAUDE)
- 2023: 43 · 2024: 164 · 2025: 533 · 2026: 119
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| VERSATREK MYCO PZA KIT (K052323) | Trek Diagnostic Systems, Inc. | 2006-01-19 |
| BACTEC MGIT 960 PZA KIT (K021582) | Becton, Dickinson & CO | 2002-07-13 |
| BACTEC MGIT 960 SIRE KITS (K014123) | Becton, Dickinson & CO | 2002-04-19 |
| BACTEC MGIT 960 SIR KITS (K003062) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2001-06-06 |
| ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING (K972772) | Trek Diagnostic Systems, Inc. | 1999-07-13 |
Track MJA automatically
Every clearance here is in the API, with alerts when new ones post.