ClearanceBrief
Company ยท US

Intl. Remote Imaging Systems

FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 2002. Name variants (Inc, Corp, punctuation) are merged.

14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
KQOAutomated Urinalysis System4
GKLCounter, Cell, Automated (Particle Counter)3
LKMCounter, Urine Particle2
GKZCounter, Differential Cell1
IBJLight, Microscope1
ICFCrystal Violet For Histology1
JJWUrinalysis Controls (Assayed And Unassayed)1
JTSStains, Microbiologic1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 21, 2002K022774IQ 200 SYSTEM
Intl. Remote Imaging Systems
LKM
Apr 14, 2000K000373939UDX URINE PATHOLOGY SYSTEM
Intl. Remote Imaging Systems
LKM
Aug 25, 1997K972141THE YELLOW IRIS URINALYSIS WORKSTATION
Intl. Remote Imaging Systems
KQO
May 13, 1996K953116WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER
Intl. Remote Imaging Systems
GKZ
Mar 22, 1996K960054900UDX URINE PATHOLOGY SYSTEM
Intl. Remote Imaging Systems
KQO
Mar 12, 1996K954006YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY
Intl. Remote Imaging Systems
GKL
Sep 20, 1994K943463THE YELLOW IRIS
Intl. Remote Imaging Systems
KQO
Mar 30, 1994K934539THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY
Intl. Remote Imaging Systems
GKL
May 1, 1992K914256YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU
Intl. Remote Imaging Systems
GKL
Jun 13, 1989K893530IRISTAIN FORMULA 2, PARTS 1 AND 2
Intl. Remote Imaging Systems
JTS
Jan 5, 1988K874207THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION
Intl. Remote Imaging Systems
IBJ
Dec 22, 1983K832713IRI SPEC URINALYSIS CONTROL
Intl. Remote Imaging Systems
JJW
Jun 17, 1983K830220YELLOW IRIS TM
Intl. Remote Imaging Systems
KQO
Jun 3, 1982K821503IRIS URINE STAIN
Intl. Remote Imaging Systems
ICF

Latest recalls

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