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Intl. Remote Imaging Systems

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
14
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K022774IQ 200 SYSTEMOctober 21, 2002
K000373939UDX URINE PATHOLOGY SYSTEMApril 14, 2000
K972141THE YELLOW IRIS URINALYSIS WORKSTATIONAugust 25, 1997
K953116WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZERMay 13, 1996
K960054900UDX URINE PATHOLOGY SYSTEMMarch 22, 1996
K954006YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITYMarch 12, 1996
K943463THE YELLOW IRISSeptember 20, 1994
K934539THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITYMarch 30, 1994
K914256YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLUMay 1, 1992
K893530IRISTAIN FORMULA 2, PARTS 1 AND 2June 13, 1989
K874207THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATIONJanuary 5, 1988
K832713IRI SPEC URINALYSIS CONTROLDecember 22, 1983
K830220YELLOW IRIS TMJune 17, 1983
K821503IRIS URINE STAINJune 3, 1982