Medical Device Manufacturer · US , Mchenry , IL

Intl. Remote Imaging Systems

14 submissions · 14 cleared · Since 1982
14
Total
14
Cleared
0
Denied

Intl. Remote Imaging Systems — FDA 510(k) Submissions

Intl. Remote Imaging Systems has submitted 14 FDA 510(k) premarket notifications since 1982, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Automated Urinalysis System, Counter, Cell, Automated (particle Counter), Counter, Urine Particle, Stains, Microbiologic, Counter, Differential Cell . Use the specialty filter in the sidebar to narrow results.

14 devices
1–14 of 14
IQ 200 SYSTEM
K022774 · LKM Counter, Urine Particle · Pathology
Oct 2002 61d
939UDX URINE PATHOLOGY SYSTEM
K000373 · LKM Counter, Urine Particle · Pathology
Apr 2000 70d
THE YELLOW IRIS URINALYSIS WORKSTATION
K972141 · KQO Automated Urinalysis System · Chemistry
Aug 1997 80d
WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER
K953116 · GKZ Counter, Differential Cell · Hematology
May 1996 315d
900UDX URINE PATHOLOGY SYSTEM
K960054 · KQO Automated Urinalysis System · Hematology
Mar 1996 78d
YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY
K954006 · GKL Counter, Cell, Automated... · Hematology
Mar 1996 200d
THE YELLOW IRIS
K943463 · KQO Automated Urinalysis System · Chemistry
Sep 1994 64d
THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY
K934539 · GKL Counter, Cell, Automated... · Microbiology
Mar 1994 194d
YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU
K914256 · GKL Counter, Cell, Automated... · Hematology
May 1992 221d
IRISTAIN FORMULA 2, PARTS 1 AND 2
K893530 · JTS Stains, Microbiologic · Pathology
Jun 1989 36d
THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION
K874207 · IBJ Light, Microscope · Pathology
Jan 1988 82d
IRI SPEC URINALYSIS CONTROL
K832713 · JJW Urinalysis Controls... · Chemistry
Dec 1983 132d
YELLOW IRIS TM
K830220 · KQO Automated Urinalysis System · Pathology
Jun 1983 144d
IRIS URINE STAIN
K821503 · ICF Crystal Violet For Histology · Pathology
Jun 1982 15d
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