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510(k) K934539

Device
THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY
Applicant
INTL. REMOTE IMAGING SYSTEMS
510(k) number
K934539
Product code
GKL  
Decision
Substantially Equivalent (SESE)
Decision date
1994-03-30
Date received
1993-09-17
Regulation
864.5200
Classification name
Counter, Cell, Automated (particle Counter)
Medical specialty
Hematology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
KENNETH LANGFORD
Address
9162 Eton Ave. Chatsworth CA US 91311 91311

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GKL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K152776Glocyte Automated Cell Counter SystemAdvanced Instruments, Inc.2016-05-27
K091539IQ 200 URINE ANALIZER BODY FLUIDS MODULEIris Diagnostics2010-08-31
K071652HEMOCUE WBC SYSTEMHemocue AB2007-10-25
K051693MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEMBayer Healthcare, LLC2005-12-07
K050235IQ 200 URINE ANALYZER BODY FLUIDS MODULEIris International, Inc.2005-03-23
K032677SYSMEX POCH-100ISysmex America, Inc.2004-02-11
K022331ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHODBayer Diagnostics Corp.2002-09-11
K001683SYSMEX R-500Sysmex Corporation of America2000-08-21
K991070COULTER Z2 ANALYZERCoulter Corp.1999-05-11
K981950SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500Sysmex Corp.1998-11-03
K981761SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZERSysmex Corp.1998-08-14
K971998ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEMBayer Corp.1997-08-29
K964375SYSMEX SE/RAM-1Sysmex Corp.1997-03-13
K962988COULTER GEN-S SYSTEMCoulter Corp.1996-10-30
K954607RETICULOCYTE METHODBayer Corp.1996-08-30

Legacy Summary#

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FDA Review#

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