Versatrek Myco Pza Kit
FDA 510(k) K052323 · Trek Diagnostic Systems, Inc.
510(k) numberK052323
Submission
- Device name
- Versatrek Myco Pza Kit
- Applicant
- Trek Diagnostic Systems, Inc.
Sun Prairie, WI, US - Received
- August 25, 2005
- Decision date
- January 19, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MJA – Susceptibility Test Powders, Antimycobacterial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Specialty
- Microbiology
Other 510(k)s with product code MJA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K021582 | Bactec Mgit 960 Pza KitMJA · Traditional | Becton, Dickinson & CO | 07/13/2002SE |
| K014123 | Bactec Mgit 960 Sire KitsMJA · Traditional | Becton, Dickinson & CO | 04/19/2002SE |
| K003062 | Bactec Mgit 960 Sir KitsMJA · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 06/06/2001SE |
| K972772 | Esp Culture System II - Myco Susceptibility TestingMJA · Traditional | Trek Diagnostic Systems, Inc. | 07/13/1999SE |
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| K103456 | The Sensititre AimLIE · Traditional | 06/22/2011SE |
| K110331 | Sensititre Aim (TM)LIE · Traditional | 04/27/2011SE |
| K093741 | Sensitive Haemophilus Influenzae, Streptococcus Pneumonia, (HP) Mic Susceptibility PlatesJWY · Traditional | 02/25/2010SE |
| K093865 | Sensititre 18-24HR Susceptibility PlatesJWY · Traditional | 02/17/2010SE |
Questions and answers
When was Versatrek Myco Pza Kit cleared by the FDA?
Versatrek Myco Pza Kit (K052323) received a 510(k) decision of Substantially Equivalent on January 19, 2006, 147 days after the submission was received.
What is the product code of K052323?
The FDA product code is MJA – Susceptibility Test Powders, Antimycobacterial, a Class II (moderate risk) device regulated under 21 CFR 866.1640.