Sensititre 18-24 Hours Susceptibility Plates
FDA 510(k) K024353 · Trek Diagnostic Systems, Inc.
510(k) numberK024353
Submission
- Device name
- Sensititre 18-24 Hours Susceptibility Plates
- Applicant
- Trek Diagnostic Systems, Inc.
Cleveland, OH, US - Received
- December 30, 2002
- Decision date
- March 6, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LTT – Panels, Test, Susceptibility, Antimicrobial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Specialty
- Microbiology
Other 510(k)s with product code LTT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL)…LTT · Traditional | Beckman Coulter, Inc. | 08/20/2025SE |
| K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)LTT · Traditional | Beckman Coulter, Inc. | 08/15/2025SE |
| K250084 | MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)LTT · Traditional | Beckman Coulter, Inc. | 07/18/2025SE |
| K202343 | MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )LTT · Traditional | Beckman Coulter, Inc. | 11/16/2020SE |
| K201423 | MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)LTT · Special | Beckman Coulter, Inc. | 06/29/2020SE |
| K193536 | MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)LTT · Traditional | Beckman Coulter, Inc. | 03/18/2020SE |
| K193358 | MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL)LTT · Traditional | Beckman Coulter, Inc. | 03/03/2020SE |
| K183127 | MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam…LTT · Traditional | Beckman Coulter, Inc. | 02/12/2019SE |
| K172337 | MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4…LTT · Traditional | Beckman Coulter, Inc. | 12/15/2017SE |
| K172912 | MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 8 µg/mL)LTT · Traditional | Beckman Coulter, Inc. | 12/07/2017SE |
More from Beckman Coulter, Inc.
| 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 Sensititre 18-24 Hours Susceptibility Plates cleared by the FDA?
Sensititre 18-24 Hours Susceptibility Plates (K024353) received a 510(k) decision of Substantially Equivalent on March 6, 2003, 66 days after the submission was received.
What is the product code of K024353?
The FDA product code is LTT – Panels, Test, Susceptibility, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1640.