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Intl. Remote Imaging Systems

FDA 510(k) & PMA Approved Devices — 14 products

Total Devices14
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K022774 IQ 200 SYSTEMLKM2002-10-21 View
510(k) K000373 939UDX URINE PATHOLOGY SYSTEMLKM2000-04-14 View
510(k) K972141 THE YELLOW IRIS URINALYSIS WORKSTATIONKQO1997-08-25 View
510(k) K953116 WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZERGKZ1996-05-13 View
510(k) K960054 900UDX URINE PATHOLOGY SYSTEMKQO1996-03-22 View
510(k) K954006 YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITYGKL1996-03-12 View
510(k) K943463 THE YELLOW IRISKQO1994-09-20 View
510(k) K934539 THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITYGKL1994-03-30 View
510(k) K914256 YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLUGKL1992-05-01 View
510(k) K893530 IRISTAIN FORMULA 2, PARTS 1 AND 2JTS1989-06-13 View
510(k) K874207 THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATIONIBJ1988-01-05 View
510(k) K832713 IRI SPEC URINALYSIS CONTROLJJW1983-12-22 View
510(k) K830220 YELLOW IRIS TMKQO1983-06-17 View
510(k) K821503 IRIS URINE STAINICF1982-06-03 View
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