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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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1 to 3 of 3 Results
Document Number K173212
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Document Parent Analyte Analyte Specialty Complexity Effective Date
DiaCarta Inc, iCOLON iFOB TEST immunochemical Fecal Occult Blood Test  
CR230770 K173212 Fecal occult blood General Chemistry WAIVED 12/01/2023
Reese Pharmaceutical Company, Reese’s ColoTest® Immunochemical Fecal Occult Blood Test  (Cassette)
CR230489 K173212 Fecal occult blood General Chemistry WAIVED 09/15/2023
Alfa Scientific Designs, Inc. Instant-view-plus Immunochemical Fecal Occult Blood Test  (Cassette)
CR170576 K173212 Fecal occult blood General Chemistry WAIVED 02/21/2018

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