510(k) K252580 ยท LKM Counter, Urine Particle
iQ200 Series
| Applicant | Beckman Coulter, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Sep 10, 2025 |
| Received | Aug 15, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K252580
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.