MJA — Susceptibility Test Powders, Antimycobacterial Class II
FDA product code MJA covers "Susceptibility Test Powders, Antimycobacterial", a Class II medical device regulated under 21 CFR 866.1640. Submissions are reviewed by the Microbiology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MJA
- Device Class
- Class II
- Regulation Number
- 866.1640
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K052323 | Trek Diagnostic Systems | VERSATREK MYCO PZA KIT | Jan 19, 2006 |
| K021582 | Becton, Dickinson And | BACTEC MGIT 960 PZA KIT | Jul 13, 2002 |
| K014123 | Becton, Dickinson And | BACTEC MGIT 960 SIRE KITS | Apr 19, 2002 |
| K003062 | Bd Becton Dickinson Vacutainer Systems Preanalytic | BACTEC MGIT 960 SIR KITS | Jun 6, 2001 |
| K972772 | Trek Diagnostic Systems | ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING | Jul 13, 1999 |