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510(k) K073055

Device
DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270
Applicant
Dade Behring, Inc.
510(k) number
K073055
Product code
JFY
Decision
Substantially Equivalent (SESE)
Decision date
2008-01-03
Date received
2007-10-30
Regulation
862.1225
Classification name
Enzymatic Method, Creatinine
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
VICTOR M CARRIO
Address
P.O. Box 6101, Ms 514 Newark DE US 19714 19714

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K103376ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CLSeppim S.A.S.2011-11-18
K110137ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URINHORIBA ABX SAS2011-08-10
K093458SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298Beckman Coulter, Inc.2009-12-04
K091742SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298Beckman Coulter, Inc.2009-08-14