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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Analyte Barbiturates Complexity waived Effective Date To 12/22/2014
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Document Parent Analyte Analyte Specialty Effective Date
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115   Barbiturates Toxicology / TDM 05/05/2011
UCP Biosciences, Inc. UCP Drug Screening Test Cups  
K110515   Barbiturates Toxicology / TDM 04/22/2011
Diagnostic Test Group Clarity Multiple Drug Screen Cups  
K091588   Barbiturates Toxicology / TDM 04/22/2011
DRUG DETECTION DEVICES, LTD. Screeners AutoCup Clinical  (OTC)
K052115   Barbiturates Toxicology / TDM 03/24/2011
UCP Biosciences, Inc. Drug Screening Test Cards  
K091588   Barbiturates Toxicology / TDM 10/18/2010
UCP Biosciences, Inc. Multiple Drug Screen Cups  
K091588   Barbiturates Toxicology / TDM 10/18/2010
NexScreen LLC, NexScreen Cup  
K082898   Barbiturates Toxicology / TDM 10/04/2010
Jant Pharmacal Corporation ACCUTEST Drug Test Cup  
K082898   Barbiturates Toxicology / TDM 09/14/2010
Confirm Biosciences Drugconfirm instant multi-drug test kit, Multi-Drug of Abuse Urine Test  
K063545   Barbiturates Toxicology / TDM 09/14/2010
Amedica Biotech AmediCheck Instant Test Cup  
K082898   Barbiturates Toxicology / TDM 09/08/2010

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