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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Analyte Fecal Occult Blood Complexity waived
 
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Document Analyte Analyte Specialty Effective Date
OSOM® iFOB Test OSOM® iFOBT Control Kit  
K121397 Fecal Occult Blood General Chemistry 01/03/2013
Medline iFOB One-Step Immunological Fecal Occult Blood Test  
K100031 Fecal Occult Blood General Chemistry 04/19/2012
Tianjin New Bay Bioresearch Co., Ltd. ForeSure IFOB Dual-Sample Fecal Occult Blood Screen Card Test  
K073431 Fecal Occult Blood General Chemistry 02/22/2012
Status iFOBT  
K100817 Fecal Occult Blood General Chemistry 10/19/2011
Orient Gene Biotech - One Step Rapid FOB  
K110309 Fecal Occult Blood General Chemistry 09/20/2011
OC-Light iFOB Test  
K041297 Fecal Occult Blood General Chemistry 03/24/2011
hema screen ER  
K102664 Fecal Occult Blood General Chemistry 02/02/2011
Siemens Hematest Reagent Tablets  (Pre-amendment device)
X100047 Fecal Occult Blood General Chemistry 12/17/2010
Centralcheck iFOBT Complete Fecal Occult Blood Test  
K063693 Fecal Occult Blood General Chemistry 11/16/2010
American IVD Biotechnology Services Inc. FOB/CRC Advanced+  
K100031 Fecal Occult Blood General Chemistry 10/04/2010

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