CLIA - Clinical Laboratory Improvement Amendments

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Analyte Barbiturates Complexity waived

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Document	Analyte	Analyte Specialty	Effective Date
Instant Technologies, Inc. iCassette Dx Drug Screen Test
K041685	Barbiturates	Toxicology / TDM	07/07/2011
Diagnostic Test Group Clarity Multi-Drug Test Cards
K091588	Barbiturates	Toxicology / TDM	06/30/2011
Diagnostic Test Group Clarity Simple Drug Screening Cups
K110515	Barbiturates	Toxicology / TDM	06/30/2011
PharmTox Rapid Exam Drug Screen Test Cup
K082898	Barbiturates	Toxicology / TDM	06/17/2011
Premier Integrity Solutions P/Tox Drug Screen Cup (OTC)
K052115	Barbiturates	Toxicology / TDM	05/05/2011
Diagnostic Test Group Clarity Multiple Drug Screen Cups
K091588	Barbiturates	Toxicology / TDM	04/22/2011
UCP Biosciences, Inc. UCP Drug Screening Test Cups
K110515	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