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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 1/1/2016 Decision Date To 1/1/2017
 
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ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CE... SIEMENS HEALTHCARE DIAGNOSTICS P030040 S011 12/25/2016
Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ ... ROCHE DIAGNOSTICS, INC. P160019 12/23/2016
ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECI... ROCHE DIAGNOSTICS CORP. P110022 S018 12/14/2016
ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICON... ROCHE DIAGNOSTICS CORP. P110025 S016 12/14/2016
ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECI... ROCHE DIAGNOSTICS CORP. P110031 S015 12/14/2016
ABBOTT ARCHITECT AUSAB ABBOTT LABORATORIES INC P050051 S032 12/09/2016
ELECSYS ANTI-HBS ROCHE DIAGNOSTICS CORP. P010054 S029 11/22/2016
ELECSYS HBEAG ROCHE DIAGNOSTICS OPERATIONS I P130015 S008 11/22/2016
ELECSYS HBSAG ROCHE DIAGNOSTICS CORP. P990012 S027 11/22/2016
ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMAT... Abbott Laboratories P110029 S024 11/10/2016
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