510(k) K243804 · LTT Panels, Test, Susceptibility, Antimicrobial
MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)
| Applicant | Beckman Coulter, Inc., West Sacramento CA, US |
| Decision | Substantially Equivalent, Aug 20, 2025 |
| Received | Dec 11, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243804
No recall in the FDA data names this 510(k).
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