Esp Culture System II - Myco Susceptibility Testing
FDA 510(k) K972772 · Trek Diagnostic Systems, Inc.
510(k) numberK972772
Submission
- Device name
- Esp Culture System II - Myco Susceptibility Testing
- Applicant
- Trek Diagnostic Systems, Inc.
Westlake, OH, US - Received
- July 24, 1997
- Decision date
- July 13, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|---|
| K052323 | Versatrek Myco Pza KitMJA · Traditional | Trek Diagnostic Systems, Inc. | 01/19/2006SE |
| 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 |
More from Bd Becton Dickinson Vacutainer Systems Preanalytic
| 510(k) | Device | Decision |
|---|---|---|
| K133038 | Sensititre Yeastone Susceptibility PlatesNGZ · Traditional | 01/31/2014SE |
| K112276 | VizionJWY · Traditional | 11/16/2011SE |
| K111615 | Sensititre 18-24 HR Susceptibility PlatesJWY · Traditional | 11/08/2011SE |
| K110583 | Sensititre OptireadLRG · Traditional | 09/22/2011SE |
| K103532 | Autoreader 2LRG · Traditional | 08/26/2011SE |
| K111429 | Sensititre (R) HP Mic Susceptibility Plate with Cefaroline (0.004-8UG/ML) and the…JWY · Traditional | 08/18/2011SE |
| 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 Esp Culture System II - Myco Susceptibility Testing cleared by the FDA?
Esp Culture System II - Myco Susceptibility Testing (K972772) received a 510(k) decision of Substantially Equivalent on July 13, 1999, 719 days after the submission was received.
What is the product code of K972772?
The FDA product code is MJA – Susceptibility Test Powders, Antimycobacterial, a Class II (moderate risk) device regulated under 21 CFR 866.1640.