510(k) K202343 · LTT Panels, Test, Susceptibility, Antimicrobial
MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )
| Applicant | Beckman Coulter, Inc., West Sacramento CA, US |
| Decision | Substantially Equivalent, Nov 16, 2020 |
| Received | Aug 18, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202343
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2026 | Beckman Coulter, Inc. MicroScan Neg MIC 56 REF C42464
UDI-DI code: 15099590731212
MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerob Open, Classified |
LTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.