LTT — Panels, Test, Susceptibility, Antimicrobial Class II
FDA product code LTT covers "Panels, Test, Susceptibility, Antimicrobial", a Class II medical device regulated under 21 CFR 866.1640. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LTT
- Device Class
- Class II
- Regulation Number
- 866.1640
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243804 | beckman coulter | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/m | August 20, 2025 |
| K250036 | beckman coulter | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg | August 15, 2025 |
| K250084 | beckman coulter | MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/m | July 18, 2025 |
| K202343 | beckman coulter | MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg | November 16, 2020 |
| K201423 | beckman coulter | MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg | June 29, 2020 |
| K193536 | beckman coulter | MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - | March 18, 2020 |
| K193358 | beckman coulter | MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16 | March 3, 2020 |
| K183127 | beckman coulter | MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/ | February 12, 2019 |
| K172337 | beckman coulter | MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/ | December 15, 2017 |
| K172912 | beckman coulter | MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 8 µ | December 7, 2017 |
| K172255 | beckman coulter | MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25 | December 1, 2017 |
| K162740 | beckman coulter | MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL) | March 21, 2017 |
| K150039 | siemens healthcare diagnostics | MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL) | July 2, 2015 |
| K131275 | siemens helathcare diagnostics | MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS | November 8, 2013 |
| K123933 | siemens healthcare diagnostics | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE | March 14, 2013 |
| K111394 | siemens healthcare diagnostics | MICROSCAN MICROSTEP | June 22, 2011 |
| K091949 | siemens healthcare diagnostics | MICROSCAN MICROSTREP PLUS, MODEL B1027-201 | January 26, 2010 |
| K091264 | siemens healthcare diagnostics | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017 | July 22, 2009 |
| K083262 | siemens healthcare diagnostics | MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ | February 18, 2009 |
| K062773 | dade behring | MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN | October 13, 2006 |