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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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1 to 10 of 500 Results *
Analyte Glucose Complexity waived Effective Date To 11/23/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
Arkray USA, Inc. GLUCOCARD Shine Blood Glucose Monitoring System  
CR140380 K120351 Glucose monitoring devices (FDA cleared/home use) General Chemistry 10/24/2014
Arriva Medical, LLC, Alere G1 Blood Glucose Monitoring System  
CR140354 K083628 Glucose monitoring devices (FDA cleared/home use) General Chemistry 10/17/2014
Wal-Mart Stores, Inc. ReliOn MICRO Blood Glucose Monitoring System  
CR140287 K142035 Glucose monitoring devices (FDA cleared/home use) General Chemistry 10/01/2014
Abbott FreeStyle Precision Neo Blood Glucose Monitoring System  
CR140251 K140371 Glucose monitoring devices (FDA cleared/home use) General Chemistry 10/01/2014
Roche Diagnostics ACCU-CHEK Performa Blood Glucose Monitoring System  
K133741   Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/30/2014
Pinnacle BioLabs Pinnacle 10SG Urinalysis  (Manual - Qualitative)
CR140349 K111999 Urine qualitative dipstick glucose Urinalysis 09/30/2014
Nova Biomedical StatStrip Glucose Hospital Meter System  
K132121   Glucose monitoring devices (prescription use only) General Chemistry 09/25/2014
CERAGEM Medisys Inc. GlucoVitaal H1A Blood Glucose Monitoring System  {Home Use} 
CR140375 K141829 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/25/2014
EosHealth, Inc., In Touch Blood Glucose Monitoring System  
CR140353 K133584 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/25/2014
ACON Laboratories, Inc., On Call Extra Blood Glucose Monitoring System  
CR140306 K132086 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/25/2014

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
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