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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Test System NameDADE DIMENSION ARX  {RANDOX LABORATORIES} 
Document NumberK010700
Analyte NameMyoglobin
Analyte SpecialtyGeneral Chemistry
ComplexityMODERATE
Effective Date06/28/2004
Device Classification Name myoglobin, antigen, antiserum, control
510(k) Number K010700
Device Name RANDOX MYOGLOBIN
Original Applicant
RANDOX LABORATORIES, LTD.
55 diamond rd.
crumlin, co. antrim,  EI bt29 4qy
Original Contact p. armstromg
Regulation Number866.5680
Classification Product Code
DDR  
Date Received03/08/2001
Decision Date 05/08/2001
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Immunology
Review Advisory Committee Clinical Chemistry
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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