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510(k) K903034

Device
RENALYZER PRX 90
Applicant
SWEDISH TRADE COUNCIL USA
510(k) number
K903034
Product code
CGL  
Decision
Substantially Equivalent (SESE)
Decision date
1991-03-13
Date received
1990-07-11
Regulation
862.1225
Classification name
Electrode, Ion Based, Enzymatic, Creatinine
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ANDERS SJOBERG
Address
150 N. Michigan Ave. Suite 1200 Chicago IL US 60601 60601

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CGL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K171059Nova StatSensor Creatinine Hospital Meter SystemNova Biomedical Corporation2017-05-26
K113726EPOC CHLORIDE TEST AND EPOC CREATININE TESTEpocal, Inc.2012-10-05
K070068NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPSNova Biomedical Corp.2007-05-07
K051968ABL8X7 FLEXRadiometer Medical Aps2006-10-16
K991727STAT PROFILE M7 ANALYZERNova Biomedical Corp.1999-07-16
K973292I-STAT SYSTEMI-Stat Corp.1997-10-20

Legacy Summary#

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FDA Review#

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