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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Test System NameRadiometer ABL System 615  
Document NumberK954612
Parent Document NumberK954612
Analyte NamePO2
Analyte SpecialtyGeneral Chemistry
ComplexityMODERATE
Effective Date02/02/1996
Device Classification Name Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
510(k) Number K954612
Device Name ABL SYSTEM 625, 615, 605
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 Number862.1120
Classification Product Code
CHL  
Subsequent Product Code
CGA  
Date Received10/05/1995
Decision Date 11/09/1995
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
Recalls CDRH Recalls
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