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510(k) K051693

Device
MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
Applicant
BAYER HEALTHCARE, LLC
510(k) number
K051693
Product code
GKL  
Decision
Substantially Equivalent (SESE)
Decision date
2005-12-07
Date received
2005-06-23
Regulation
864.5200
Classification name
Counter, Cell, Automated (particle Counter)
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ANDREA HOLLE
Address
511 Benedict Ave. Tarrytown NY US 10591 10591

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
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
K954006YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITYIntl. Remote Imaging Systems1996-03-12

Legacy Summary#

summary

FDA Review#

Decision Summary