Iris Diagnostics
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 3 spellings of its name, each linked to the record.
- Device recalls: 4
- 510(k) clearances: 3
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| May 12, 2017 | iChemVELOCITY Automated Urine Chemistry SystemK171083 · JIL | 510(k) clearances |
| Jul 15, 2015 | iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714,Class II · Iris International is recalling the iChemVELOCITY systems because they do not maintain the on-board strip stability clai | Device recalls |
| Dec 3, 2014 | RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4. The RTH8 rotor Class II · Iris International is recalling the RTH8 Rotor used in the StatSpin Express 4 Horizontal Centrifuge because the RTH8 rot | Device recalls |
| Sep 18, 2012 | Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use withClass II · The firm initiated this recall because complaints from customers reported that the recovery compared to assigned assay | Device recalls |
| Jul 9, 2012 | IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayClass III · The firm recalled after it received complaints of IRISpec CA/CB two part Urine Chemistry Control, 101131-12, where the n | Device recalls |
| Aug 31, 2010 | IQ 200 URINE ANALIZER BODY FLUIDS MODULEK091539 · GKL | 510(k) clearances |
| Dec 21, 2007 | IRISPEC,CA/CB/CCK072640 · JJW | 510(k) clearances |
Names and Identifiers
- Appears as
- Website
- danaher.com
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