MJA — Susceptibility Test Powders, Antimycobacterial Class II
FDA Device Classification
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 | January 19, 2006 |
| K021582 | becton, dickinson and | BACTEC MGIT 960 PZA KIT | July 13, 2002 |
| K014123 | becton, dickinson and | BACTEC MGIT 960 SIRE KITS | April 19, 2002 |
| K003062 | bd becton dickinson vacutainer systems preanalytic | BACTEC MGIT 960 SIR KITS | June 6, 2001 |
| K972772 | trek diagnostic systems | ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING | July 13, 1999 |