Susceptibility Test Powders, Antimycobacterial
Antimycobacterial Susceptibility Test Powders are reference reagents consisting of known concentrations of antimycobacterial drugs prepared in powder form, used to prepare dilution series for testing the susceptibility of Mycobacterium species, including Mycobacterium tuberculosis, to various antibiotics in a laboratory setting. They are classified as Class 2 devices under 21 CFR 866.1640 in the Microbiology specialty and require 510(k) premarket notification. They carry no implant or life-sustaining flags.
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Basic Information
- Product Code
- MJA
- Device Class
- FDA class 2
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K052323 | VERSATREK MYCO PZA KIT | Jan 19, 2006 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
| K021582 | BACTEC MGIT 960 PZA KIT | Jul 13, 2002 | Substantially Equivalent | Becton, Dickinson & CO |
| K014123 | BACTEC MGIT 960 SIRE KITS | Apr 19, 2002 | Substantially Equivalent | Becton, Dickinson & CO |
| K003062 | BACTEC MGIT 960 SIR KITS | Jun 06, 2001 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K972772 | ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING | Jul 13, 1999 | Substantially Equivalent | Trek Diagnostic Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.