Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of SysmexLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Iris International with 4 510(k) clearances. The most recent is a 510(k) clearance dated Mar 23, 2011: CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT.
| Mar 23, 2011 | CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KITK101852 · KQO | 510(k) clearances |
| Feb 5, 2010 | IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLEK093861 · LKM | 510(k) clearances |
| Jun 13, 2006 | ICHEM 100 URINE CHEMISTRY ANALYZERK060280 · JIL | 510(k) clearances |
| Mar 23, 2005 | IQ 200 URINE ANALYZER BODY FLUIDS MODULEK050235 · GKL | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
