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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Test System NameHELENA LABORATORIES COLOSCREEN-ES  
Document NumberK003359
Analyte NameFecal occult blood
Analyte SpecialtyGeneral Chemistry
ComplexityWAIVED
Effective Date12/13/2000
Device Classification Name reagent, occult blood
510(k) Number K003359
Device Name COLOSCREEN-ES
Original Applicant
HELENA LABORATORIES
1530 lindbergh dr.
p.o. box 752
beaumont,  TX  77704
Original Contact pat franks
Regulation Number864.6550
Classification Product Code
KHE  
Date Received10/27/2000
Decision Date 11/27/2000
Decision substantially equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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