510(k) K210127 ยท LKM Counter, Urine Particle
iQ200 System, iChemVELOCITY Automated Urine Chemistry System
| Applicant | Beckman Coulter, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Jul 2, 2021 |
| Received | Jan 19, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210127
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2026 | Beckman Coulter, Inc. DxU 840m Iris, REF: C76947;
DxU 850m Iris, REF: C49513 Open, Classified |
KQO | None listed |
| Oct 15, 2026 | Beckman Coulter, Inc. IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997;
IQ200 SELECT, REF: 700-3340, 700-3345, 700-3347, B48998, C10684;
IQ200 ELITE, REF: 700-3370, 700-3375, 700-3375RFB, 700-3376, B4899 Open, Classified |
KQO | None listed |
| May 17, 2023 | Beckman Coulter, Inc. iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-vitro diagnostic device, urine analysis, c) iQ200 Se Open, Classified |
KQO | None listed |
| May 17, 2023 | Beckman Coulter, Inc. DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis Open, Classified |
KQO | None listed |
| May 17, 2023 | Beckman Coulter, Inc. DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis Open, Classified |
KQO | None listed |
| May 17, 2023 | Beckman Coulter, Inc. UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis Open, Classified |
KQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.