Sensititre Aim (TM)
FDA 510(k) K110331 · Trek Diagnostic Systems, Ltd.
510(k) numberK110331
Submission
- Device name
- Sensititre Aim (TM)
- Applicant
- Trek Diagnostic Systems, Ltd.
Cleveland, OH, US - Received
- February 3, 2011
- Decision date
- April 27, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LIE – Reagent/Device, Inoculum Calibration
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Specialty
- Microbiology
Other 510(k)s with product code LIE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221493 | MicroScan Prompt Inoculation System-DLIE · Traditional | Beckman Coulter, Inc. | 04/05/2023SE |
| K103456 | The Sensititre AimLIE · Traditional | Trek Diagnostic Systems | 06/22/2011SE |
| K935566 | Sensi-Cal Amco AEPA-1LIE · Traditional | Radiometer America, Inc. | 03/29/1994SE |
| K911059 | Turbidometric StandardLIE · Traditional | Scientific Device Laboratory, Inc. | 06/10/1991SE |
| K890339 | Difco Director Inoculation SystemLIE · Traditional | Difco Laboratories, Inc. | 02/07/1989SE |
| K820299 | Prompt Inoculation SystemLIE · Traditional | 3M Company | 03/15/1982SE |
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| 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 |
| K093741 | Sensitive Haemophilus Influenzae, Streptococcus Pneumonia, (HP) Mic Susceptibility PlatesJWY · Traditional | 02/25/2010SE |
| K093865 | Sensititre 18-24HR Susceptibility PlatesJWY · Traditional | 02/17/2010SE |
| K092445 | Sensititre 18-24 Hour Susceptibility PlatesJWY · Traditional | 12/16/2009SE |
Questions and answers
When was Sensititre Aim (TM) cleared by the FDA?
Sensititre Aim (TM) (K110331) received a 510(k) decision of Substantially Equivalent on April 27, 2011, 83 days after the submission was received.
What is the product code of K110331?
The FDA product code is LIE – Reagent/Device, Inoculum Calibration, a Class II (moderate risk) device regulated under 21 CFR 866.1640.