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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Test System NameRadiometer EML 105  
Document NumberK952621
Parent Document NumberK952621
Analyte NamePotassium
Analyte SpecialtyGeneral Chemistry
ComplexityMODERATE
Effective Date12/08/1995
Device Classification Name Glucose Oxidase, Glucose
510(k) Number K952621
Device Name EML105 ELECTROLYTE METABOLITE ANALYZER
Applicant
Radiometer America, Inc.
810 Sharon Dr.
Westlake,  OH  44145
Applicant Contact DONALD L BAKER
Correspondent
Radiometer America, Inc.
810 Sharon Dr.
Westlake,  OH  44145
Correspondent Contact DONALD L BAKER
Regulation Number862.1345
Classification Product Code
CGA  
Date Received06/08/1995
Decision Date 10/17/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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