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Iris Diagnostics

4 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080 recall (Z-2441-2015)Iris Diagnostics2015-08-21
RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, recall (Z-0857-2015)Iris Diagnostics2014-12-23
Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. P recall (Z-1328-2013)Iris Diagnostics2013-05-15
IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800 recall (Z-2124-2012)Iris Diagnostics2012-08-01

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Every clearance here is in the API, with alerts when new ones post.