Company ยท US
Iris Diagnostics
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2010. Name variants (Inc, Corp, punctuation) are merged.
2510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 21, 2015 | Iris Diagnostics iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714, 800-7719, 800-7720. An in vitro diagnostic device used to a Terminated |
KQO | K101852 |
| Dec 23, 2014 | Iris Diagnostics RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4.
The RTH8 rotor is used with the Statspin Express 4 Horizontal Centrifuge. Sta Terminated |
JQC | None listed |
| May 15, 2013 | Iris Diagnostics Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12.
Product Usage: For in vitro diagnostic use with the iQ200 series. Terminated |
JJW | K832713 |
| Aug 1, 2012 | Iris Diagnostics IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074.
Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes a Terminated |
JJW | K945913 |