K193358 is an FDA 510(k) clearance for the MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL). This device is classified as a Panels, Test, Susceptibility, Antimicrobial (Class II - Special Controls, product code LTT).
Submitted by Beckman Coulter, Inc. (West Sacramento, US). The FDA issued a Cleared decision on March 3, 2020, 90 days after receiving the submission on December 4, 2019.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K193358 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 2019 |
| Decision Date | March 03, 2020 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LTT — Panels, Test, Susceptibility, Antimicrobial |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |