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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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Device
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PMA
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DIASORIN ETI-EBK PLUS ASSAY DIASORIN, INC. P990043 S021 06/08/2016
ETI-AB-AUK PLUS ASSAY DIASORIN, INC. P990042 S017 06/08/2016
ETI-MAK-2 PLUS ASSAY AND HBsAg CONFIRMATORY TEST A... DIASORIN, INC. P990038 S021 06/08/2016
ELECSYS HBSAG ROCHE DIAGNOSTICS CORP. P990012 S027 11/22/2016
ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMAT... ROCHE DIAGNOSTICS CORP. P990012 S026 03/16/2016
ELECSYS HBSAG TEST SYSTEM ROCHE DIAGNOSTICS CORP. P990012 S025 02/24/2016
ELECSYS HBSAG IMMUNOASSAY ROCHE DIAGNOSTICS CORP. P990012 S024 08/08/2016
Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ ... ROCHE DIAGNOSTICS, INC. P160019 12/23/2016
ELECSYS HBEAG ROCHE DIAGNOSTICS OPERATIONS I P130015 S008 11/22/2016
ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTR... ROCHE DIAGNOSTICS OPERATIONS I P130015 S007 10/24/2016
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