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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 46 Results
productcode LOM PMA Number p Decision Date From 1/1/2014 Decision Date To 1/1/2015
 
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PMA
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ARCHITECT AUSAB ASSAY ABBOTT LABORATORIES INC P050051 S025 01/09/2014
ETI-MAK-2 PLUS ASSAY DIASORIN, INC. P990038 S019 01/10/2014
ETI-AB-EBK PLUS ASSAY DIASORIN, INC. P990041 S018 01/10/2014
ETI-AB-AUK PLUS ASSAY DIASORIN, INC. P990042 S015 01/10/2014
ETI-EBK PLUS DIASORIN, INC. P990043 S019 01/10/2014
ETI-CORE-IGMK PLUS DIASORIN, INC. P990044 S016 01/10/2014
ETI-AB-COREK PLUS ASSAY DIASORIN, INC. P990045 S016 01/10/2014
ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATORS Ortho-Clinical Diagnostics, In P000014 S027 03/10/2014
ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTR... ROCHE DIAGNOSTICS OPERATIONS I P130015 03/14/2014
MONOLISA ANTI-HBC IGM EIA Bio-Rad Laboratories, Inc. P060034 S008 03/19/2014
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