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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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1 to 10 of 11 Results
Document Number K050741
 
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Universal Meditech Inc., DiagnosUS hCG Pregnancy Urine Test - Cassette Format  
CR180888 K050741 Urine hCG by visual color comparison tests Endocrinology WAIVED 01/23/2019
Medline Industries Medline hCG Urine Pregnancy Test Device  
K050741 K050741 Urine hCG by visual color comparison tests Endocrinology WAIVED 04/10/2012
Independent Medical Co-Op, Inc., IMCO Pregnancy Test  
K050741 K050741 Urine hCG by visual color comparison tests Endocrinology WAIVED 02/02/2011
JANT Pharmacal Corp. Accutest Value+ hCG Urine Pregnancy Test Device  
K050741 K050741 Urine hCG by visual color comparison tests Endocrinology WAIVED 01/24/2011
Great Lakes Medical Trading Accurate Diagnostics Pregnancy Test  
K050741 K050741 Urine hCG by visual color comparison tests Endocrinology WAIVED 01/24/2011
SCI International, Inc. U-Check Pregnancy Test Cassette Format  
K050741 K050741 Urine hCG by visual color comparison tests Endocrinology WAIVED 09/09/2009
SCI International, Inc. Baby Test Pregnancy Test Cassette Format  
K050741 K050741 Urine hCG by visual color comparison tests Endocrinology WAIVED 09/09/2009
BTNX Inc. Rapid Response hCG Pregnancy Test Cassette Format  
K050741 K050741 Urine hCG by visual color comparison tests Endocrinology WAIVED 03/16/2009
SCI International Inc. New Choice Pro hCG Pregnancy Test Cassette Format  
K050741 K050741 Urine hCG by visual color comparison tests Endocrinology WAIVED 01/05/2009
Heritage House '76 Inc., The Precious Feet Premium Pregnancy Test  
K050741 K050741 Urine hCG by visual color comparison tests Endocrinology WAIVED 10/24/2007

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