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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Document Number K945187
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Roche Diagnostics, cobas pro integrated solutions, cobas c 703  {ONLINE DAT Methaqualone} 
CR260281 K945187 Methaqualone Toxicology / TDM MODERATE 04/28/2026
Roche Diagnostics, cobas c 303  {ONLINE DAT Methaqualone} 
CR220440 k945187 Methaqualone Toxicology / TDM MODERATE 12/05/2022
Roche Diagnostics cobas c 503 analytical unit  
CR200050 K945187 Methaqualone Toxicology / TDM MODERATE 02/21/2020
Roche Diagnostics cobas c 502 Analyzer  
K100853 K945187 Methaqualone Toxicology / TDM MODERATE 01/10/2011
Olympus AU5400  {Roche Diagnostics Online DAT Methaqualone} 
K945187 K945187 Methaqualone Toxicology / TDM MODERATE 04/15/2010
Roche Diagnostics cobas c 311 Analyzer  
K945187 K945187 Methaqualone Toxicology / TDM MODERATE 01/22/2008
Roche Diagnostics cobas c 501 Analyzer  
K945187 K945187 Methaqualone Toxicology / TDM MODERATE 03/28/2007

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