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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Analyte Oxycodone Complexity waived Effective Date To 10/21/2014
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Document Parent Analyte Analyte Specialty Effective Date
US Diagnostics Inc. UScreen Drugs of Abuse Cup  
K122904   Oxycodone Toxicology / TDM 01/30/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cards  
K123863   Oxycodone Toxicology / TDM 01/10/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cups  
K123863   Oxycodone Toxicology / TDM 01/10/2013
American Screening Corporation, Inc., Multi-Drug Testing Cups  
K110515   Oxycodone Toxicology / TDM 01/04/2013
American Screening Corporation, Inc., Multi-Drug Testing Cards  
K091588   Oxycodone Toxicology / TDM 01/04/2013
Clinical Reference Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115   Oxycodone Toxicology / TDM 01/03/2013
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Cassette Tests  
K123080   Oxycodone Toxicology / TDM 11/29/2012
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Dip Card Tests  
K123080   Oxycodone Toxicology / TDM 11/29/2012
Alere iCup DX Drug Screen Cup  
K052115   Oxycodone Toxicology / TDM 11/27/2012
Wondfo Multi-Drug Urine Test Cup  (Cup format)
K122904   Oxycodone Toxicology / TDM 11/16/2012

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