510(k) K093861 ยท LKM Counter, Urine Particle
IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE
| Applicant | Iris International, Inc., Chatsworth CA, US |
| Decision | Substantially Equivalent, Feb 5, 2010 |
| Received | Dec 16, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093861
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.