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510(k) K973292

Device
I-STAT SYSTEM
Applicant
I-STAT CORP.
510(k) number
K973292
Product code
CGL  
Decision
Substantially Equivalent (SESE)
Decision date
1997-10-20
Date received
1997-09-02
Regulation
862.1225
Classification name
Electrode, Ion Based, Enzymatic, Creatinine
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
IMANTS R LAUKS
Address
303 College Rd. E. Princeton NJ US 08540 08540

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
K903034RENALYZER PRX 90Swedish Trade Council USA1991-03-13

Legacy Summary#

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FDA Review#

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