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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Test System NameRoche Diagnostics Hitachi 717  {RANDOX LABORATORIES MYOGLOBIN TEST KIT} 
Document NumberK010700
Analyte NameMyoglobin
Analyte SpecialtyGeneral Chemistry
ComplexityMODERATE
Effective Date05/18/2001
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,  IE 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 (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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