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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Analyte Cannabinoids (THC) Complexity waived Effective Date To 07/29/2014
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Document Parent Analyte Analyte Specialty Effective Date
Jant Pharmacal Corp. Accutest Multi X Drug Cup Test  
K071489   Cannabinoids (THC) Toxicology / TDM 10/23/2012
Clinical Research Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115   Cannabinoids (THC) Toxicology / TDM 10/23/2012
Revolution Diagnostics Corp. AccuSeal Pro Instant Test Cup  
K071489   Cannabinoids (THC) Toxicology / TDM 10/11/2012
Medimpex United, Inc. MedimpexQ Test Multi X Drug Cup Test  
K071489   Cannabinoids (THC) Toxicology / TDM 10/05/2012
IND Diagnostic IND Home Marijuana Test - Cassette Format  
K121231   Cannabinoids (THC) Toxicology / TDM 08/02/2012
IND Diagnostic IND Home Drug Test - Multi-Panel Cassette Format  
K121231   Cannabinoids (THC) Toxicology / TDM 08/02/2012
IND Diagnostic IND Home Marijuana Test - Strip Format  
K121231   Cannabinoids (THC) Toxicology / TDM 08/02/2012
IND Diagnostic IND Home Drug Test - Multi-Panel Strip Format  
K121231   Cannabinoids (THC) Toxicology / TDM 08/02/2012
Wondfo Cannabinoids Urine Test  (Cup format)
K121557   Cannabinoids (THC) Toxicology / TDM 07/27/2012
Wondfo Cannabinoids Urine Test  (Dip Card format)
K121557   Cannabinoids (THC) Toxicology / TDM 07/27/2012

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