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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Test System NameBeckman Coulter AU680 Chemistry Analyzer  
Document NumberK981743
Parent Document NumberK944768
Analyte NamePhosphorus
Analyte SpecialtyGeneral Chemistry
ComplexityMODERATE
Effective Date10/04/2011
Device Classification Name Phosphomolybdate (Colorimetric), Inorganic Phosphorus
510(k) Number K944768
Device Name OLYMPUS INORGANIC PHOSPHORUS REAGENT
Applicant
Olympus America, Inc.
4 Nevada Dr.
Lake Success,  NY  11042
Applicant Contact LAURA STORMS-TYLER
Correspondent
Olympus America, Inc.
4 Nevada Dr.
Lake Success,  NY  11042
Correspondent Contact LAURA STORMS-TYLER
Regulation Number862.1580
Classification Product Code
CEO  
Date Received09/27/1994
Decision Date 03/24/1995
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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