LTT
- Product code
- LTT
- Device name
- Panels, Test, Susceptibility, Antimicrobial
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.1640
- Medical specialty
- Microbiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 50 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K243804 | 2025-08-20 | Beckman Coulter, Inc. | MicroScan Dried Gram-Negative MIC/Combo Panels with … | |
| K250036 | 2025-08-15 | Beckman Coulter, Inc. | MicroScan Dried Gram-Positive MIC/Combo Panels with … | |
| K250084 | 2025-07-18 | Beckman Coulter, Inc. | MicroScan Dried Gram-Negative MIC/Combo Panels with … | FDA |
Official FDA classification page: LTT
Classification and pathway per current FDA publications. Data from openFDA (CC0).